Trial Outcomes & Findings for An MRI Investigation of Soft Tissues in Total Hip Arthroplasty (NCT NCT01750606)
NCT ID: NCT01750606
Last Updated: 2026-02-20
Results Overview
Determine the percentage of asymptomatic vs symptomatic Metal-on-Metal and Metal-on-Poly patients with a soft tissue mass
Recruitment status
COMPLETED
Target enrollment
397 participants
Primary outcome timeframe
Patients 1 year post-implantation up to 10 years post implantation
Results posted on
2026-02-20
Participant Flow
Pre-THA cases who are consented to provide blood samples that serve as the baseline for the metal ion testing. Post-Operative cases cases with an existing MoP or MoM hip replacement in the specified timeframe who have been consented to participate in the study. Post-Operative Description of Analysis Cohort for each Post-Operative Group: M2a \> 144; Meta on Poly \> 100; M2a 38 \> 24-72; M2a Taper \> 16-48; M2a Ringloc \> 24-72; Total \> 308-436
Participant milestones
| Measure |
M2a Ringloc Hip
Patients receiving a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004.
|
M2a Taperloc Hip
Patients receiving a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003.
|
Pre-THA
Patients who are planned but have not yet received a total hip arthroplasty. No intervention or treatment - blood draw only to be used as a surrogate baseline for metal ion exposure.
|
M2a Magnum Hip
Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2011.
|
M2a38 Hip
Patients receiving a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006.
|
Metal-on-Poly
Patients receiving a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
14
|
104
|
140
|
60
|
79
|
|
Overall Study
COMPLETED
|
9
|
13
|
104
|
137
|
56
|
78
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
3
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
Baseline characteristics by cohort
| Measure |
Pre-THA
n=104 Participants
Patients who are prospectively planned but have not yet received a total hip arthroplasty. No intervention or treatment - blood draw only to be used as a surrogate baseline for metal ion exposure.
|
Metal-on-Poly
n=78 Participants
Retrospectively enrolled patients who received a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006.
|
M2a Magnum Hip
n=132 Participants
Retrospectively enrolled patients who received a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2011.
|
M2a38 Hip
n=54 Participants
Retrospectively enrolled patients who received a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006.
|
M2a Ringloc Hip
n=9 Participants
Retrospectively enrolled patients who received a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004.
|
M2a Taperloc Hip
n=13 Participants
Retrospectively enrolled patients who received a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003.
|
Total
n=390 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
1 Year Cohort
|
—
|
—
|
59.5 years
n=12 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
51.5 years
n=1 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
—
|
—
|
55.5 years
n=13 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
|
Age, Customized
2 Year Cohort
|
—
|
—
|
57.3 years
n=20 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
—
|
—
|
—
|
57.3 years
n=20 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
|
Age, Customized
3 Year Cohort
|
—
|
—
|
56.8 years
n=24 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
—
|
—
|
—
|
56.8 years
n=24 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
|
Age, Customized
4 Year Cohort
|
—
|
—
|
57.8 years
n=22 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
—
|
—
|
—
|
57.8 years
n=22 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
|
Age, Customized
5 Year Cohort
|
—
|
—
|
59.7 years
n=27 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
—
|
—
|
—
|
59.7 years
n=27 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
|
Age, Customized
6 Year Cohort
|
—
|
67.8 years
n=25 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
57.2 years
n=26 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
59.8 years
n=5 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
—
|
—
|
61.6 years
n=56 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
|
Age, Customized
7 Year Cohort
|
—
|
69.1 years
n=20 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
—
|
58.6 years
n=23 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
—
|
—
|
63.85 years
n=43 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
|
Age, Customized
8 Year Cohort
|
—
|
73.6 years
n=12 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
67.3 years
n=1 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
57.1 years
n=24 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
34.7 years
n=1 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
—
|
58.18 years
n=38 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
|
Age, Customized
9 Year Cohort
|
—
|
64.0 years
n=21 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
—
|
—
|
40 years
n=3 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
52.5 years
n=3 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
52.17 years
n=27 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
|
Age, Customized
10 Year Cohort
|
—
|
—
|
—
|
54.5 years
n=1 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
50.9 years
n=5 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
51.1 years
n=10 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
52.17 years
n=16 Participants • Age data analysis was generated for FDA reports and stratified by the 'X Year Cohort' which was defined as the time from surgery date (e.g. 1 Year Cohort was considered 1-year post-op). The Pre-THA cohort, which included blood draw analysis for subjects that had not undergone THA, did not include age in the data collection. Thus, pre-THA data has been set to 0 for all cohort years.
|
|
Sex: Female, Male
Female
|
55 Participants
n=104 Participants
|
54 Participants
n=78 Participants
|
52 Participants
n=132 Participants
|
25 Participants
n=54 Participants
|
8 Participants
n=9 Participants
|
5 Participants
n=13 Participants
|
199 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=104 Participants
|
24 Participants
n=78 Participants
|
80 Participants
n=132 Participants
|
29 Participants
n=54 Participants
|
1 Participants
n=9 Participants
|
8 Participants
n=13 Participants
|
191 Participants
n=390 Participants
|
PRIMARY outcome
Timeframe: Patients 1 year post-implantation up to 10 years post implantationPopulation: Patients in each symptomatic group evaluated with an adverse local tissue reaction (ALTR), which is determined based on the presence of an age-related macular degeneration (ARMD) of any level of severity, detected on the MRI. Patients in each asymptomatic group evaluated without an ALTP detected on the MRI.
Determine the percentage of asymptomatic vs symptomatic Metal-on-Metal and Metal-on-Poly patients with a soft tissue mass
Outcome measures
| Measure |
M2a 38mm Hip- 1 Year Cohort
n=1 Participants
Patients receiving a Biomet metal on metal M2a38mm hip, 1 Year Postop
|
M2a 38mm Hip- 6 Year Cohort
n=5 Participants
Patients receiving a Biomet metal on metal M2a38mm hip, 6 Years Postop
|
M2a 38mm Hip- 7 Year Cohort
n=26 Participants
Patients receiving a Biomet metal on metal M2a38mm hip, 7 Years Postop
|
M2a 38mm Hip- 8 Year Cohort
n=27 Participants
Patients receiving a Biomet metal on metal M2a 38mm hip, 8 Years Postop
|
M2a 38mm Hip- 10 Year Cohort
n=1 Participants
Patients receiving a Biomet metal on metal M2a 38mm hip, 10 Years Postop
|
M2a Magnum Hip- 1 Year Cohort
n=12 Participants
Patient receiving a Biomet M2a Magnum Hip, 1 Year Postop
|
M2a Magnum Hip- 2 Year Cohort
n=20 Participants
Patient receiving a Biomet M2a Magnum Hip, 2 Years Postop
|
M2a Magnum Hip- 3 Year Cohort
n=27 Participants
Patient receiving a Biomet M2a Magnum Hip, 3 Years Postop
|
M2a Magnum Hip- 4 Year Cohort
n=25 Participants
Patient receiving a Biomet M2a Magnum Hip, 4 Years Postop
|
M2a Magnum Hip- 5 Year Cohort
n=27 Participants
Patient receiving a Biomet M2a Magnum Hip, 5 Years Postop
|
M2a Magnum Hip- 6 Year Cohort
n=28 Participants
Patient receiving a Biomet M2a Magnum Hip, 6 Years Postop
|
M2a Magnum Hip- 8 Year Cohort
n=1 Participants
Patient receiving a Biomet M2a Magnum Hip, 8 Years Postop
|
M2a Ringloc Hip- 8 Year Cohort
n=1 Participants
Patient receiving a Biomet M2a Ringloc Hip, 8 Years Postop
|
M2a Ringloc Hip- 9 Year Cohort
n=3 Participants
Patient receiving a Biomet M2a Ringloc Hip, 9 Years Postop
|
M2a Ringloc Hip- 10 Year Cohort
n=5 Participants
Patient receiving a Biomet M2a Ringloc Hip, 10 Years Postop
|
M2a Taper Hip- 9 Year Cohort
n=3 Participants
Patient receiving a Biomet M2a Taper Hip, 9 Years Postop
|
M2a Taper Hip- 10 Year Cohort
n=11 Participants
Patient receiving a Biomet M2a Taper Hip, 10 Years Postop
|
Metal on Poly Hip- 6 Year Cohort
n=25 Participants
Patient receiving a Biomet Metal on Poly Hip, 6 Years Postop
|
Metal on Poly Hip- 7 Year Cohort
n=20 Participants
Patient receiving a Biomet Metal on Poly Hip, 7 Years Postop
|
Metal on Poly Hip- 8 Year Cohort
n=12 Participants
Patient receiving a Biomet Metal on Poly Hip, 8 Years Postop
|
Metal on Poly Hip- 9 Year Cohort
n=22 Participants
Patient receiving a Biomet Metal on Poly Hip, 9 Years Postop
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass
Symptomatic
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
|
Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass
Asymptomatic
|
1 Participants
|
5 Participants
|
22 Participants
|
23 Participants
|
1 Participants
|
8 Participants
|
18 Participants
|
26 Participants
|
23 Participants
|
25 Participants
|
26 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
8 Participants
|
25 Participants
|
20 Participants
|
10 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 1 Year through 10 Years PostopPopulation: The Analysis group does not include the 104 subjects from the Pre-operative group and the 9 subjects that were Screen Failures
The outcome measure will show the number of subjects in all post-operative cohorts determined to have metal ion concentrations in whole blood and serum \>7ppb in each study arm.
Outcome measures
| Measure |
M2a 38mm Hip- 1 Year Cohort
n=78 Participants
Patients receiving a Biomet metal on metal M2a38mm hip, 1 Year Postop
|
M2a 38mm Hip- 6 Year Cohort
n=137 Participants
Patients receiving a Biomet metal on metal M2a38mm hip, 6 Years Postop
|
M2a 38mm Hip- 7 Year Cohort
n=56 Participants
Patients receiving a Biomet metal on metal M2a38mm hip, 7 Years Postop
|
M2a 38mm Hip- 8 Year Cohort
n=9 Participants
Patients receiving a Biomet metal on metal M2a 38mm hip, 8 Years Postop
|
M2a 38mm Hip- 10 Year Cohort
n=13 Participants
Patients receiving a Biomet metal on metal M2a 38mm hip, 10 Years Postop
|
M2a Magnum Hip- 1 Year Cohort
Patient receiving a Biomet M2a Magnum Hip, 1 Year Postop
|
M2a Magnum Hip- 2 Year Cohort
Patient receiving a Biomet M2a Magnum Hip, 2 Years Postop
|
M2a Magnum Hip- 3 Year Cohort
Patient receiving a Biomet M2a Magnum Hip, 3 Years Postop
|
M2a Magnum Hip- 4 Year Cohort
Patient receiving a Biomet M2a Magnum Hip, 4 Years Postop
|
M2a Magnum Hip- 5 Year Cohort
Patient receiving a Biomet M2a Magnum Hip, 5 Years Postop
|
M2a Magnum Hip- 6 Year Cohort
Patient receiving a Biomet M2a Magnum Hip, 6 Years Postop
|
M2a Magnum Hip- 8 Year Cohort
Patient receiving a Biomet M2a Magnum Hip, 8 Years Postop
|
M2a Ringloc Hip- 8 Year Cohort
Patient receiving a Biomet M2a Ringloc Hip, 8 Years Postop
|
M2a Ringloc Hip- 9 Year Cohort
Patient receiving a Biomet M2a Ringloc Hip, 9 Years Postop
|
M2a Ringloc Hip- 10 Year Cohort
Patient receiving a Biomet M2a Ringloc Hip, 10 Years Postop
|
M2a Taper Hip- 9 Year Cohort
Patient receiving a Biomet M2a Taper Hip, 9 Years Postop
|
M2a Taper Hip- 10 Year Cohort
Patient receiving a Biomet M2a Taper Hip, 10 Years Postop
|
Metal on Poly Hip- 6 Year Cohort
Patient receiving a Biomet Metal on Poly Hip, 6 Years Postop
|
Metal on Poly Hip- 7 Year Cohort
Patient receiving a Biomet Metal on Poly Hip, 7 Years Postop
|
Metal on Poly Hip- 8 Year Cohort
Patient receiving a Biomet Metal on Poly Hip, 8 Years Postop
|
Metal on Poly Hip- 9 Year Cohort
Patient receiving a Biomet Metal on Poly Hip, 9 Years Postop
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Metal Ion Concentrations in Whole Blood and Serum > 7ppb
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Metal-on-Poly
Serious events: 78 serious events
Other events: 0 other events
Deaths: 0 deaths
M2a Magnum Hip (1-3 Years)
Serious events: 58 serious events
Other events: 0 other events
Deaths: 0 deaths
M2a Magnum Hip (4-8 Years)
Serious events: 79 serious events
Other events: 0 other events
Deaths: 0 deaths
M2a38 Hip
Serious events: 56 serious events
Other events: 0 other events
Deaths: 0 deaths
M2a Ringloc Hip
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
M2a Taperloc Hip
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metal-on-Poly
n=78 participants at risk
Patients receiving a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006.
|
M2a Magnum Hip (1-3 Years)
n=58 participants at risk
Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2009.
|
M2a Magnum Hip (4-8 Years)
n=79 participants at risk
Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2009 and January 1, 2011.
|
M2a38 Hip
n=56 participants at risk
Patients receiving a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006.
|
M2a Ringloc Hip
n=9 participants at risk
Patients receiving a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004.
|
M2a Taperloc Hip
n=13 participants at risk
Patients receiving a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Ambulation Difficulties
|
9.0%
7/78 • Number of events 7 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.7%
1/58 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.1%
4/79 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.1%
4/56 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Vascular disorders
Artery Damage/Vascular Disorder
|
0.00%
0/78 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
3.4%
2/58 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/79 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.8%
1/56 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
14.1%
11/78 • Number of events 11 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
12.1%
7/58 • Number of events 7 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.6%
6/79 • Number of events 6 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
16.1%
9/56 • Number of events 9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
11.1%
1/9 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Decreased Range Of Motion
|
5.1%
4/78 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
8.6%
5/58 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.1%
4/79 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
8.9%
5/56 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.7%
1/13 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Infections and infestations
Discoloration/Rash In Wound Area
|
1.3%
1/78 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/58 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
3.8%
3/79 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.8%
1/56 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.7%
1/13 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Injury, poisoning and procedural complications
Dislocation/Subluxation
|
1.3%
1/78 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/58 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/79 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.7%
1/13 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Infections and infestations
Early/Late Infection
|
2.6%
2/78 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
6.9%
4/58 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.3%
1/79 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.1%
4/56 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Effusion >3 Mos
|
0.00%
0/78 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/58 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.3%
1/79 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.8%
1/56 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Femoral Fracture
|
0.00%
0/78 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/58 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.3%
1/79 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Grinding/Negative Sensation In Hip
|
5.1%
4/78 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.7%
1/58 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
2.5%
2/79 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.4%
3/56 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
15.4%
2/13 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Heterotopic Ossification
|
3.8%
3/78 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
6.9%
4/58 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
3.8%
3/79 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
11.1%
1/9 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Implant Fracture
|
0.00%
0/78 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.7%
1/58 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/79 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Implant Loosening/ Radiolucency
|
3.8%
3/78 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.2%
3/58 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.3%
1/79 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
10.7%
6/56 • Number of events 6 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Joint Deformity
|
0.00%
0/78 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.7%
1/58 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
2.5%
2/79 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.4%
3/56 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Knee/Ankle Problems Ipsilateral Side
|
51.3%
40/78 • Number of events 40 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
22.4%
13/58 • Number of events 13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
21.5%
17/79 • Number of events 17 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
17.9%
10/56 • Number of events 10 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
33.3%
3/9 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
23.1%
3/13 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Leg Length Discrepancy
|
32.1%
25/78 • Number of events 25 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
13.8%
8/58 • Number of events 8 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
8.9%
7/79 • Number of events 7 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
12.5%
7/56 • Number of events 7 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
44.4%
4/9 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
15.4%
2/13 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Limp> 3 Mos Post-Op
|
71.8%
56/78 • Number of events 56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
20.7%
12/58 • Number of events 12 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
22.8%
18/79 • Number of events 18 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
44.6%
25/56 • Number of events 25 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
33.3%
3/9 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
46.2%
6/13 • Number of events 6 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Loss Of Function Compared To Pre-Op
|
7.7%
6/78 • Number of events 6 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.7%
1/58 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
6.3%
5/79 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.4%
3/56 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Mild/Moderate Pain
|
1.3%
1/78 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/58 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/79 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
78.2%
61/78 • Number of events 61 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
31.0%
18/58 • Number of events 18 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
40.5%
32/79 • Number of events 32 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
44.6%
25/56 • Number of events 25 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
77.8%
7/9 • Number of events 7 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
69.2%
9/13 • Number of events 9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Nervous system disorders
Nerve Damage/Nerve Palsy
|
2.6%
2/78 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/58 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/79 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.8%
1/56 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Nervous system disorders
Numbness
|
1.3%
1/78 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/58 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/79 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Other - Right Foot Problem
|
0.00%
0/78 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.7%
1/58 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/79 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Pelvic Fracture
|
0.00%
0/78 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.7%
1/58 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.3%
1/79 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Vascular disorders
Phlebitis
|
1.3%
1/78 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/58 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/79 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Severe Pain > 3 Mos Post-Op
|
12.8%
10/78 • Number of events 10 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
15.5%
9/58 • Number of events 9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
16.5%
13/79 • Number of events 13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
14.3%
8/56 • Number of events 8 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
44.4%
4/9 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.7%
1/13 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Snapping/Popping/Other Audible Noise
|
3.8%
3/78 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
6.9%
4/58 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.6%
6/79 • Number of events 6 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
25.0%
14/56 • Number of events 14 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
22.2%
2/9 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
38.5%
5/13 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Stiffness
|
2.6%
2/78 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.7%
1/58 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.1%
4/79 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.1%
4/56 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
22.2%
2/9 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Tenderness At Implant Site > 3 Mos Post-Op
|
6.4%
5/78 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
12.1%
7/58 • Number of events 7 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
8.9%
7/79 • Number of events 7 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.4%
3/56 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.7%
1/13 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Trochanteric Avulsion
|
1.3%
1/78 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/58 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.3%
1/79 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.7%
1/13 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Unexplained Mass Or Swelling
|
1.3%
1/78 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
3.4%
2/58 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
8.9%
7/79 • Number of events 7 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
10.7%
6/56 • Number of events 6 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Skin and subcutaneous tissue disorders
Wound Problems> 3mos Post-Op
|
3.8%
3/78 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.7%
1/58 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
8.9%
7/79 • Number of events 7 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.8%
1/56 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.7%
1/13 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Immune system disorders
Allergy/Immunological
|
1.3%
1/78 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
6.9%
4/58 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.1%
4/79 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.1%
4/56 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
11.1%
1/9 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
15.4%
2/13 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Ear and labyrinth disorders
Auditory
|
3.8%
3/78 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.2%
3/58 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
2.5%
2/79 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
3.6%
2/56 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.7%
1/13 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Cardiac disorders
Cardiopulmonary
|
52.6%
41/78 • Number of events 41 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
8.6%
5/58 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
19.0%
15/79 • Number of events 15 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
21.4%
12/56 • Number of events 12 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
33.3%
3/9 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
38.5%
5/13 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Skin and subcutaneous tissue disorders
Dermotology (Not At Implant Site)
|
7.7%
6/78 • Number of events 6 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.7%
1/58 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
6.3%
5/79 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
10.7%
6/56 • Number of events 6 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
11.1%
1/9 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.7%
1/13 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Endocrine disorders
Endocrine
|
24.4%
19/78 • Number of events 19 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/58 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
6.3%
5/79 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
12.5%
7/56 • Number of events 7 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
11.1%
1/9 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Gastrointestinal disorders
Gastrointestinal
|
21.8%
17/78 • Number of events 17 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
3.4%
2/58 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
6.3%
5/79 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
19.6%
11/56 • Number of events 11 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
22.2%
2/9 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
23.1%
3/13 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Blood and lymphatic system disorders
Hematological (Not At Implant Site)
|
3.8%
3/78 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
10.3%
6/58 • Number of events 6 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.1%
4/79 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
8.9%
5/56 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
15.4%
2/13 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Blood and lymphatic system disorders
Lymphatic
|
6.4%
5/78 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/58 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
2.5%
2/79 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Nervous system disorders
Neurological
|
3.8%
3/78 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.7%
1/58 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
3.8%
3/79 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.1%
4/56 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
11.1%
1/9 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Nervous system disorders
Neurological (Not At Implant Site)
|
57.7%
45/78 • Number of events 45 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
8.6%
5/58 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
24.1%
19/79 • Number of events 19 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
21.4%
12/56 • Number of events 12 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
44.4%
4/9 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
46.2%
6/13 • Number of events 6 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Eye disorders
Ocular/Visual
|
6.4%
5/78 • Number of events 5 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/58 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.1%
4/79 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.1%
4/56 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.7%
1/13 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
General disorders
Other
|
0.00%
0/78 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
1.7%
1/58 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/79 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/56 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/9 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Psychiatric disorders
Psychiatric
|
7.7%
6/78 • Number of events 6 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
3.4%
2/58 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
3.8%
3/79 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
12.5%
7/56 • Number of events 7 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
22.2%
2/9 • Number of events 2 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
0.00%
0/13 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
|
Renal and urinary disorders
Urogenital
|
12.8%
10/78 • Number of events 10 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
5.2%
3/58 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
3.8%
3/79 • Number of events 3 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
7.1%
4/56 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
11.1%
1/9 • Number of events 1 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
30.8%
4/13 • Number of events 4 • Surgery to 10 years post operative
Adverse events (AEs) were collected for participants who completed at least the 3-month post-op evaluation. This excludes 104 pre-THA subjects who served as a control cohort and had not undergone device implantation, as well as 9 screen failures. All AEs were summarized in the Serious Adverse Events table, as events were not prospectively categorized by seriousness; therefore, no separate non-serious AE summary is available and the Other Adverse Events table reports zero participants at risk.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place