Trial Outcomes & Findings for R3 Delta Ceramic Acetabular System PAS U.S. (NCT NCT03056534)
NCT ID: NCT03056534
Last Updated: 2025-04-13
Results Overview
Number of participants with overall study success were identified as "Success" or "Failure" where success indicated all the following: * No component revision for any reason * Modified Harris Hip Score (mHHS) greater than or equal to 80 points * No radiographic failure (Radiographic failure was defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones, no femoral or acetabular subsidence greater than or equal to 5 mm from baseline, and no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score.)
Recruitment status
COMPLETED
Target enrollment
189 participants
Primary outcome timeframe
3 Years Postoperative
Results posted on
2025-04-13
Participant Flow
Overall, 232 participants were screened with 189 participants enrolled to the study at 10 sites; however, 3 sites were terminated early due to lack of enrollment.
Participant milestones
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Overall Study
STARTED
|
189
|
|
Overall Study
COMPLETED
|
131
|
|
Overall Study
NOT COMPLETED
|
58
|
Reasons for withdrawal
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Overall Study
Participant withdrew consent
|
8
|
|
Overall Study
Participant not able to return
|
6
|
|
Overall Study
Lost to Follow-up
|
37
|
|
Overall Study
Investigator judgment
|
1
|
|
Overall Study
Death
|
4
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Screen fail due to femoral stem implanted not being allowed per protocol
|
1
|
Baseline Characteristics
R3 Delta Ceramic Acetabular System PAS U.S.
Baseline characteristics by cohort
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=189 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Age, Continuous
|
58.60 years
STANDARD_DEVIATION 12.75 • n=99 Participants
|
|
Age, Customized
Age Group · < 65
|
112 Participants
n=99 Participants
|
|
Age, Customized
Age Group · >= 65
|
77 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
37 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
146 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
189 participants
n=99 Participants
|
|
Operative Side
Left
|
88 Participants
n=99 Participants
|
|
Operative Side
Right
|
101 Participants
n=99 Participants
|
|
Body Mass Index (BMI)
|
29.00 kg/m^2
STANDARD_DEVIATION 5.01 • n=99 Participants
|
PRIMARY outcome
Timeframe: 3 Years PostoperativePopulation: Overall number of participants with data collected for the time frame indicated.
Number of participants with overall study success were identified as "Success" or "Failure" where success indicated all the following: * No component revision for any reason * Modified Harris Hip Score (mHHS) greater than or equal to 80 points * No radiographic failure (Radiographic failure was defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones, no femoral or acetabular subsidence greater than or equal to 5 mm from baseline, and no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score.)
Outcome measures
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=113 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Overall Study Success at 3 Years Postoperative
Success
|
100 Participants
|
|
Overall Study Success at 3 Years Postoperative
Failure
|
13 Participants
|
PRIMARY outcome
Timeframe: 3 Years PostoperativePopulation: Overall number of participants with data collected for the time frame indicated.
Number of participants component revisions identified as "Success" or "Failure" with success defined as no component revision for any reason.
Outcome measures
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=136 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Component Revisions at 3 Years Postoperative
Success
|
135 Participants
|
|
Component Revisions at 3 Years Postoperative
Failure
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 Years postoperativePopulation: Overall number of participants with data collected for the time frame indicated.
The Harris Hip Score (HHS) is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. The modified Harris Hip Score (mHHS) includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranges from 0 (worst) to 95 (best). The number of participants were identified as "Success" or "Failure" with success defined as a mHHS that is greater than or equal to 80 points.
Outcome measures
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=124 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Number of Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points
Success
|
114 Participants
|
|
Number of Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points
Failure
|
10 Participants
|
PRIMARY outcome
Timeframe: 3 Years PostoperativePopulation: Overall number of participants with data collected for the time frame indicated.
Number of participants with overall radiographic success identified as "Success" or "Failure" where success indicated all of the following: * No radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones * No femoral or acetabular subsidence greater than or equal to 5 mm from baseline * No acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score
Outcome measures
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=108 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Overall Radiographic Success at 3 Years Postoperative
Success
|
106 Participants
|
|
Overall Radiographic Success at 3 Years Postoperative
Failure
|
2 Participants
|
PRIMARY outcome
Timeframe: 3 Years postoperativePopulation: Overall number of participants with data collected for the time frame indicated.
Number of participants identified as "Success" or "Failure" with success defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones
Outcome measures
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=119 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Number of Participants With Absence of Radiolucency at 3 Years Postoperative
Success
|
119 Participants
|
|
Number of Participants With Absence of Radiolucency at 3 Years Postoperative
Failure
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 Years postoperativePopulation: Overall number of participants with data collected for the time frame indicated.
Number of participants identified as "Success" or "Failure" with success defined as no femoral subsidence or acetabular migration greater than or equal to 5 millimeters (mm) from baseline.
Outcome measures
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=119 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Number of Participants With Absence of Femoral Subsidence or Acetabular Migration at 3 Years Postoperative
Success
|
119 Participants
|
|
Number of Participants With Absence of Femoral Subsidence or Acetabular Migration at 3 Years Postoperative
Failure
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 Years postoperativePopulation: Overall number of participants with data collected for the time frame indicated.
Number of participants identified as "Success" or "Failure" with success defined as no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score.
Outcome measures
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=108 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Number of Participants With Absence of Acetabular Cup Inclination Changes Greater Than 4 Degrees From Baseline at 3 Years Postoperative
Success
|
106 Participants
|
|
Number of Participants With Absence of Acetabular Cup Inclination Changes Greater Than 4 Degrees From Baseline at 3 Years Postoperative
Failure
|
2 Participants
|
SECONDARY outcome
Timeframe: Preoperative, 3 months, 1 year, 2 years, 3 yearsPopulation: Overall number of participants with data collected for the time frame indicated.
The Harris Hip Score (HHS) is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. The modified Harris Hip Score (mHHS) includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranges from 0 (worst) to 95 (best).
Outcome measures
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=184 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Modified Hip Harris Score (mHHS)
Preoperative
|
47.60 score on a scale
Standard Deviation 11.52
|
|
Modified Hip Harris Score (mHHS)
3 months
|
89.60 score on a scale
Standard Deviation 10.93
|
|
Modified Hip Harris Score (mHHS)
1 year
|
91.10 score on a scale
Standard Deviation 12.02
|
|
Modified Hip Harris Score (mHHS)
2 years
|
93.00 score on a scale
Standard Deviation 10.37
|
|
Modified Hip Harris Score (mHHS)
3 years
|
93.50 score on a scale
Standard Deviation 8.97
|
SECONDARY outcome
Timeframe: 3 months, 1 year, 2 yearsPopulation: Overall number of participants with data collected for the time frame indicated.
The number of participants identified as either "Success" or "Failure" with success defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" pain modified Harris Hip Score (mHHS).
Outcome measures
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=156 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Radiographic Findings: Number of Participants With Absence of Radiolucency
2 years · Failure
|
0 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Radiolucency
3 months · Success
|
155 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Radiolucency
3 months · Failure
|
1 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Radiolucency
1 year · Success
|
142 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Radiolucency
1 year · Failure
|
0 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Radiolucency
2 years · Success
|
135 Participants
|
SECONDARY outcome
Timeframe: 3 months, 1 year, 2 yearsPopulation: Overall number of participants with data collected for the time frame indicated.
The number of participants identified as either "Success" or "Failure" with success defined as no femoral subsidence or acetabular migration greater than or equal to 5 millimeters (mm) from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" pain modified Harris Hip Score (mHHS).
Outcome measures
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=156 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration
3 months · Success
|
156 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration
3 months · Failure
|
0 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration
1 year · Success
|
142 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration
1 year · Failure
|
0 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration
2 years · Success
|
135 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration
2 years · Failure
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months, 1 year, and 2 yearsPopulation: Overall number of participants with data collected for the time frame indicated.
Number of participants identified as "Success" or "Failure" with success defined as no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" pain modified Harris Hip Score (mHHS).
Outcome measures
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=141 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes
3 months · Success
|
137 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes
3 months · Failure
|
4 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes
1 year · Success
|
127 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes
1 year · Failure
|
3 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes
2 years · Success
|
122 Participants
|
|
Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes
2 years · Failure
|
3 Participants
|
SECONDARY outcome
Timeframe: Postoperatively, up to 3 yearsPopulation: Overall number of participants with data collected for the time frame indicated.
The Kaplan-Meier estimate of implant survivorship was measured from date of surgery to date of final visit with survival defined as no revision for any reason. A revision indicated reoperation was needed where any component (acetabular cup, acetabular liner, femoral head, or femoral stem) was replaced.
Outcome measures
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=187 Participants
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Implant Survivorship Kaplan-Meier Estimate
|
99.4 percentage of participants
Interval 96.1 to 99.9
|
Adverse Events
R3™ Biolox® Delta Ceramic Acetabular System
Serious events: 70 serious events
Other events: 101 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=189 participants at risk
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Left Knee Osteoarthristis
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
INTRAOPERATIVE PERIPROSTHETIC FRACTURE OF RIGHT FEMUR
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
FALL AND DELIRIUM DUE TO HYPONATREMIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
INCREASED SHORTNESS OF BREATH, HYPOTENSION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RIGHT BREAST CANCER
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
ANAPHYLACTIC REACTION TO LEFT KNEE INJECTION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
General disorders
DENTAL PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT KNEE ARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP ARTHRITIS
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
INGUINAL HERNIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
ILEITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
SEVERE DEGENERATIVE JOINT DISEASE, LEFT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS LEFT HIP
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN RIGHT WRIST
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
CELLULITIS OF RIGHT LOWER LEG
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RECURRENT DISLOCATION OF LEFT TOTAL HIP ARTHROPLASTY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Eye disorders
BILATERAL EYE CATARACT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS LEFT KNEE
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Eye disorders
LEFT EYE PAIN, CORNEAL EROSION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Blood and lymphatic system disorders
CALCULUS OF GALLBLADDER WITH ACUTE CHOLECYSTITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
LEFT-SIDED NUMBNESS AND WEAKNESS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP OSTEOARTHRITIS
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER ROTATOR CUFF ARTHROPATHY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
SEIZURE, ENCEPHALOPATHY
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT AND RIGHT KNEE PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
CLOSED FRACTURE OF DISTAL END OF RIGHT FIBULA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
SEVERE DEGENERATIVE JOINT DISEASE, RIGHT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOMA, NOSE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY, ATRIAL FIBRILLATION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
LEAD NOISE ON RV
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
CHEST WALL HEMATOMA AT PACEMAKER SITE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LOW BACK PAIN
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER IMPINGEMENT, ACROMIOCLAVICULAR JOINT ARTHROSIS, BICEPS TENDINITIS AND ROTATOR CUFF FRA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Reproductive system and breast disorders
SYPHILIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
DEGENERATIVE ARTHRITIS, RIGHT KNEE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
LUMBAR STENOSIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS, RIGHT HIP
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
ACUTE CHOLECYSTITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP PAIN AND DISCOMFORT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SOLITARY BRAIN METASTASIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER, LEFT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
General disorders
CHEST PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Eye disorders
BILATERAL PTOSIS OF UPPER EYELIDS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP DISLOCATION, CONTUSION OF RIGHT THUMB WI
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
LEFT HIP POSTOPERATIVE PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL BLEEDING
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP ARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
GANGLION CYST OF TENDON SHEATH OF RIGHT HAND
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP PAIN SECONDARY TO OSTEOARTHRITIS
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Product Issues
FAILED TOTAL HIP JOINT (RIGHT SIDE)
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
PERICOLONIC ABSCESS S/P APPENDECTOMY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
ACUTE NONPERFORATED APPENDICITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
SPINAL STENOSIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS, LEFT KNEE
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PATIENT DIAGNOSED WITH CANCER, AGGRESSIVE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PRIMARY OSTEOARTHRITIS LEFT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
CALCAR FRATURE INTRAOPERATIVELY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
GLENOHUMERAL JOINT OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP OSTEOARTHRITIS - WORSENING PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
KNEE OSTEOARTHRITIS, BILATERAL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
TYPHOID FEVER - PNEUMONIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
SEVERE RIGHT HIP OSTEOARTHRITIS
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
HIP OSTEOARTHRITIS (LEFT HIP)
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT KNEE OSTEOARTHRITIS
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN TUMOR
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP ARTHROPLASTY (TOTAL) FOR AVN (AVASCULAR
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
AVASCULAR NECROSIS OF BONE OF LEFT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
GASTRITIS WITH NAUSEA AND VOMITING
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT TOTAL KNEE REPLACEMENT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
DEATH DUE TO DRUG OVERDOSE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT INTRAOPERATIVE CALCAR FRACTURE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT TOTAL KNEE REPLACEMENT DUE TO POST-TRAUMATIC
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS IN RIGHT HIP
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
SWELLING LEFT IN HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
BILIARY COLIC
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
BILATERAL SHOULDER ARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
CERVICAL MYELORADICULOPATHY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
END STAGE RIGHT SHOULDER ARTHRITIS
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
PELVIC AND LEFT HUMERUS FRACTURES DUE TO FALL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
WORSENING LEFT KNEE OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
WORSENING LEFT HIP OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
WORSENING RIGHT HIP OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
BILATERAL HIP PAIN DUE TO ROAD TRAFFIC ACCIDENT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
HERNIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Renal and urinary disorders
WORSENING NEPHROTIC SYNDROME
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
Other adverse events
| Measure |
R3™ Biolox® Delta Ceramic Acetabular System
n=189 participants at risk
Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System
|
|---|---|
|
Musculoskeletal and connective tissue disorders
L KNEE OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
INTRAOPERATIVE PERIPROSTHETIC FRACTURE OF RIGHT FEMUR
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
PAIN RIGHT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
FALL AND DELIRIUM DUE TO HYPONATREMIA.
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
INCREASED SHORTNESS OF BREATH, HYPOTENSION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
SUPERFICIAL PROXIMAL WOUND DEHISCENCE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
IT BAND TIGHTNESS (LEFT)
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
RADICULAR PAIN, LEFT HIP/LEG
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
OCCASIONAL ACHE AT TIP OF STEM
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PAIN, LEFT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
ANAPHYLACTIC REACTION TO LEFT KNEE INJECTION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
RAISED PROSTATE SPECIFIC ANTIGEN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RECURRENT DISLOCATION OF LEFT TOTAL HIP ARTHROPLASTY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID FLARES
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT ANKLE PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
SYNCOPE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Metabolism and nutrition disorders
HYPERLIPIDEMIA
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
LEAD NOISE ON RV
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
MILD DISCOMFORT RIGHT HIP TROCHANTER REGION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP ARTHRITIS
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
CHEST WALL HEMATOMA AT PACEMAKER SITE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
RIGHT ANKLE SPRAIN, RIGHT GASTROCNEMIUS STRAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RIGHT BREAST CANCER
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT KNEE ARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY, ATRIAL FIBRILLATION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.6%
3/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
HYPERTENSION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLEMIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
SEVERE DEGENERATIVE JOINT DISEASE, LEFT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
FULL BODY HIVES
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
ACUTE NON-RECURRENT SINUSITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Metabolism and nutrition disorders
ELEVATED LOW DENSITY LIPOPROTEIN LEVEL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
CARDIAC ARRYTHMIAS
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANEMIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS LEFT HIP
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
SQUEAKING, LEFT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
1.6%
3/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
ACUTE LEFT HIP PAIN, LUMBAR STRAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP PSOAS TENDINITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
BLUNT CHEST TRAUMA, SUBACUTE RIB FRACTURES
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
CELLULITIS OF RIGHT LOWER LEG
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
ACUTE PANSINUSITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
HYPOKALEMIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
LEFT BUTTOCK ABSCESS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
LACERATION OF SCALP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT BREAST PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
HIP PAIN, RIGHT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT CARPOMETACARPAL OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS LEFT KNEE
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Eye disorders
BILATERAL EYE CATARACT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PAINFUL TOAL KNEE ARTHROPLASTY (RIGHT KNEE)
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
1.6%
3/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT LATERAL EPICONDYLITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Ear and labyrinth disorders
TINEA CORPORIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
ILEITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PATELLAR TENDINITIS, RIGHT KNEE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
INGUINAL HERNIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
EPIGASTRIC/CHEST PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION, COUGH
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
LEFT HIP PAIN
|
3.7%
7/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
INFLUENZA
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN, NAUSEA, DIARRHEA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Ear and labyrinth disorders
ACUTE SUPPURATIVE OTITIS MEDIA OF RIGHT EAR WITHOUT SPONTANEOUS RUPTURE OF TYMPANIC MEMBRANE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
RIGHT FOOT EXTENSOR TENDONITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT GLUTEAL PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
GERD WITHOUT ESOPHAGITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
THROMBOSED HEMORRHOID
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
THROAT DISCOMFORT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PATIENT DIAGNOSED WITH CANCER, AGGRESSIVE.
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Eye disorders
LEFT EYE PAIN, CORNEAL EROSION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Eye disorders
LAGOPHTHALMOS OF EYELIDS OF BOTH EYES
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
SINUSITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Eye disorders
ABRASION OF RIGHT CORNEA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
LUMBAR RADICULOPATHY, LOW BACK PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
THORACIC RADICULOPATHY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Blood and lymphatic system disorders
CALCULUS OF GALLBLADDER WITH ACUTE CHOLECYSTITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
LEFT-SIDED NUMBNESS AND WEAKNESS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
HIGH STOMACH ACID
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
TRAVELER'S DIARRHEA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
HEMORRHOIDS, EXTERNAL, THROMBOSED
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
CYST IN CERVICAL, OVARY, UTERUS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Hepatobiliary disorders
ACUTE CHOLECYSTITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
PELVIC AND LEFT HUMERUS FRACTURES DUE TO FALL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
STREPTOCOCOCCUS B
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
NAUSEA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL BLEEDING
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT GREAT TOE PAIN (HALLUX RIGIDUS)
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
RIGHT GREATER TROCHANTERIC PAIN SYNDROME
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
SEIZURE, ENCEPHALOPATHY
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
General disorders
PELVIC PAIN
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
ACUTE NONPERFORATED APPENDICITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
TRAUMATIC ARTHRITIS OF RIGHT ANKLE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
GASTRITIS WITH NAUSEA AND VOMITING
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
PERICOLONIC ABSCESS S/P APPENDECTOMY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Reproductive system and breast disorders
VAGINAL ATROPHY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
HERNIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
CLOSED FRACTURE OF DISTAL END OF RIGHT FIBULA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
ACUTE CYSTITIS WITH HEMATURIA AND DYSURIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
COVID-19
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Metabolism and nutrition disorders
ELEVATED BLOOD GLUCOSE LEVELS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
PERSISTENT SEVERE HEADACHES
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Ear and labyrinth disorders
NON-RECURRENT ACUTE SEROUS OTITIS MEDIA OF BOTH EARS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
VIRAL CONJUNCTIVITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
ONYCHOMYCOSIS, RIGHT TOENAIL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
General disorders
DEHYDRATION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
VESTIBULAR MIGRAINES
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT KNEE PAIN
|
4.2%
8/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
SEVERE DEGENERATIVE JOINT DISEASE, RIGHT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOMA, NOSE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP PAIN
|
3.7%
7/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT GROIN PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
DENTAL PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HAND PAIN AND FOREARM PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP ARTHRITIS
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN RIGHT SHOULDER
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGITIS AND RHINORRHEA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGITIS WITH COUGH
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LOW BACK PAIN
|
2.6%
5/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER IMPINGEMENT,ACROMIOCLAVICULAR JOINT ARTHROSIS,BICEPS TENDINITIS & ROTATOR CUFF FRAYING
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
BICEPS TENDINITIS, LEFT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN RIGHT WRIST
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
DYSLIPIDEMIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Reproductive system and breast disorders
SYPHILIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HAND PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP ARTHROPLASTY (TOTAL) FOR AVN (AVASCULAR NECROSIS)
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Ear and labyrinth disorders
FLUID LEVEL BEHIND TYMPANIC MEMBRANE OF BOTH EARS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
PINCHING SENSATION IN RIGHT HIP WHEN LIFTING HEAVY OBJECTS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
HYPERBILIRUBINEMIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
BILATERAL KNEE PAIN
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
ACUTE INTRACTABLE HEADACHE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
ALLERGIES
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
BAKER'S CYST BEHIND RIGHT KNEE AND SWELLING OF RIGHT KNEE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Reproductive system and breast disorders
MIDLINE CYSTOCELE, PAIN IN FEMALE GENITALIA ON INTERCOURSE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
TRIGGER FINGER, LEFT HAND MIDDLE FINGER
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
DEGENERATIVE ARTHRITIS, RIGHT KNEE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
TENDINITIS, RIGHT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
INSOMNIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
BILATERAL FOOT PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
CLOSED FRACTURE OF MULTIPLE RIBS, LEFT SIDE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
SHINGLES
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP DISLOCATION & THUMB CONTUSION W/O NAIL DAMAGE, CLOSED FRACTURE OF LEFT-SIDE MULTIPLE RIBS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP FLEXOR TENDINITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS, RIGHT KNEE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Reproductive system and breast disorders
LEFT LOWER MEDIAL BREAST PAIN AND LUMP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
MUSCLE SPASMS
|
1.6%
3/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
HYPOVITAMINOSIS D
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
LIPOMA ON RIGHT LOWER EXTREMITY BELOW KNEE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
RIGHT HIP NOISE
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
DEGENERATIVE ARTHRITIS, RIGHT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
LEFT GREATER TROCHANTERIC BURSITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
RIGHT HIP NOISE ASSOCIATED WITH NO PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
HERPES ZOSTER WITHOUT COMPLICATION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
POLYCYTHEMIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
POSITIVE COVID19
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
LUMBAR SPONDYLOSIS, DEGENERATIVE DISC DISEASE, RADICULOPATHY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
HALLUX RIGIDUS, RIGHT FOOT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
LEFT HIP CLICKING AND SQUEAKING WITHOUT PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN, LOW BACK PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT AND RIGHT KNEE PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
BILATERAL TARSOMETATARSAL ARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
WOUND INFECTION, RIGHT LOWER LEG
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
LUMBAR STENOSIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS, RIGHT HIP
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
SACROILIITIS, UNKNOWN SIDE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS, RIGHT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT ANKLE PAIN
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN RIGHT KNEE, RIGHT KNEE OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER, LEFT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HEEL PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
TROCHANTERIC BURSITIS, BILATERAL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP PAIN
|
4.2%
8/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
HEADACHES
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
RIGHT HIP PAIN
|
4.2%
8/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SOLITARY BRAIN METASTASIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
LEFT HIP SORENESS AND POPPING
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Eye disorders
BILATERAL PTOSIS OF UPPER EYELIDS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Renal and urinary disorders
FREQUENT NIGHT URINATION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
LEFT HIP POSTOPERATIVE PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
MIXED HYPERLIPIDEMIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
SLEEP APNEA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT LOWER BACK PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
CERVICAL RADICULOPATHY WITH NUMBNESS AND TINGLING OF LEFT HAND
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT KNEE OSTEOARTHRITIS, LEFT KNEE PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
ELEVATED GLUCOSE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
LOW HIGH DENSITY LIPOPROTEIN LEVEL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN LEFT SHOULDER
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP PAIN AND DISCOMFORT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
RIGHT HIP PAIN POST-OP LAMINECTOMY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
INGROWN TOENAIL ON LEFT BIG TOE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP PAIN SECONDARY TO OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
POSTERIOR NECK LIPOMA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
RIGHT HIP SORENESS AND NOISE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
SEVERE ACUTE SYNDROME CORONAVIRUS 2
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
ALLERGIC REACTION TO ORAL RIVAROXABAN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
RIGHT HIP TROCHANTERIC BURSITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
GANGLION CYST OF TENDON SHEATH OF RIGHT HAND
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT ILIOPSOAS TENDINITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT INTRAOPERATIVE CALCAR FRACTURE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
HYPERLIPIDEMIA
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP PAIN SECONDARY TO OSTEOARTHRITIS
|
1.6%
3/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
RIGHT IT BAND TENDINITIS, GREATER TROCHANTERIC BURSITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
LEFT NECK PAIN AND SWELLING OF PORT CATHETER
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
General disorders
CHEST PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
TROCHANTERIC BURSITIS OF RIGHT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP PAIN / PRIMARY OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
LUPUS (EARLY STAGE DIAGNOSIS)
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT ELBOW PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
ACUTE LOW BACK PAIN DUE TO A FALL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT IT BAND TIGHTNESS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Product Issues
FAILED TOTAL HIP JOINT (RIGHT SIDE)
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT KNEE ARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
RIGHT KNEE PAIN
|
2.1%
4/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
General disorders
POST-OP FEVERS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HEEL AND FOOT PAIN AND SWELLING
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
ANKLE PAIN, LEFT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT KNEE PAIN
|
2.1%
4/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
SPINAL STENOSIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
ILIOPSOAS TENDINITIS OF THE LEFT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
GREATER TROCHANTERIC BURSITIS, RIGHT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS, LEFT KNEE
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
POST-OPERATIVE SQUEAKING, LEFT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Eye disorders
PRIMARY OPEN-ANGLE GLAUCOMA, BILATERAL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT KNEE PAIN - UNILATERAL PRIMARY KNEE OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT LOWER EXTREMITY PAIN AND SWELLING
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
CALCAR FRATURE INTRAOPERATIVELY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
SUPRAPATELLAR BURSITIS OF LEFT KNEE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
RIGHT LUNG LOWER LOBE PULMONARY NODULE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS OF MCP JOINT, RIGHT THUMB
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
LEFT KNEE PAIN SECONDARY TO FALL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
RIGHT OLECRANON BURSITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
WORSENING RIGHT SHOULDER PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
GLENOHUMERAL JOINT OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
PAIN AT INCISION SITE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT PSOAS TENDINITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
KNEE OSTEOARTHRITIS, BILATERAL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT RING TRIGGER FINGER, LEFT WRIST DE QUERVAIN'S
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT ANKLE FRACTURE (DISTAL FIBULA)
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
WORSENING LEFT KNEE PAIN SECONDARY TO OSTEOARTHRITIS
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
MILD TRAUMA TO OPERATIVE HIP. PATIENT BUMPED INTO METAL POLE.
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
GOUT. LEFT ANKLE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
TORN ROTATOR CUFF
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
FALL
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER PAIN
|
1.6%
3/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Infections and infestations
TYPHOID FEVER - PNEUMONIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
LEFT TROCHANTERIC BURSITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
SEVERE RIGHT HIP OSTEOARTHRITIS
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
ILIOPSOAS TENDINITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP OSTEOARTHRITIS - WORSENING PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PRIMARY OSTEOARTHRITIS LEFT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
HIP OSTEOARTHRITIS (LEFT HIP)
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT KNEE OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
SHINGLES (VARICELLA ZOSTER)
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN TUMOR
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LUMBAR BACK PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
MINOR FALL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PROXIMAL BICEPS TENDINOPATHY RIGHT SHOULDER
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
TRAUMATIC INJURY OF HEAD
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
NEUROPLASTY RIGHT CARPAL TUNNEL RELEASE DUE TO ARTHRITIS OF CARPOMETACARPAL
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
FOLLOW-UP BILATERAL HIP DISCOMFORT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
AVASCULAR NECROSIS OF BONE OF LEFT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER ROTATOR CUFF ARTHROPATHY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
RIGHT THIGH NUMBNESS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT TOTAL KNEE REPLACEMENT DUE TO POST-TRAUMATIC ARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS IN RIGHT HIP
|
1.1%
2/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
WORSENING RIGHT LEG PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
BILATERAL LOW BACK PAIN WITHOUT SCIATICA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Nervous system disorders
LUMBAR DEGENERATIVE DISC DISEASE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
SWELLING LEFT IN HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT THIGH PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
INCREASED LEFT HIP PAIN
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PAIN FOR RIGHT TOTAL HIP ARTHROPLASTY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
INCREASED/WORSENING RIGHT HIP PAIN OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
General disorders
FEVER
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Renal and urinary disorders
STAGE 2 KIDNEY DISEASE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Gastrointestinal disorders
FREQUENT EPISTAXIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP BURSITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT BUNION WITH ARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
LEFT BASILAR JOINT ARTHRITIS OF THE THUMB
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
BILATERAL SHOULDER ARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
CERVICAL MYELORADICULOPATHY
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
END STAGE RIGHT SHOULDER ARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
PSOAS TENDINITIS, RIGHT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
WORSENING LEFT KNEE OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
FALL INVOLVING RIGHT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Vascular disorders
PURE HYPERCHOLESTEROLEMIA
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
WORSENING LEFT HIP OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
BURSITIS IN RIGHT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
CRAMPS, MUSCLE SPASM
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
WORSENING RIGHT HIP OSTEOARTHRITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
FACIAL LESION
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
ALLERGIC REACTION (RASH) ON TRUNK OF BODY.
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
ADVERSE DRUG REACTION TO BACTRIM
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
BILATERAL HIP PAIN DUE TO ROAD TRAFFIC ACCIDENT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASM AND ILIOPSOAS TENDINITIS
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Renal and urinary disorders
WORSENING NEPHROTIC SYNDROME
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
RIGHT TOTAL KNEE REPLACEMENT
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Congenital, familial and genetic disorders
WORSENING CONGENITAL DYSPLASIA LEFT HIP
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Injury, poisoning and procedural complications
DEATH DUE TO DRUG OVERDOSE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
FRACTURED LEFT ANKLE
|
0.53%
1/189 • Adverse events were collected upon implantation of device through study completion, up to 3 years.
|
Additional Information
Senior Manager Clinical Compliance
Smith+Nephew, Inc
Phone: +44 7811 407089
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period up to 90 days but less than or equal to 180 days from the time submitted to the sponsor for review. Sponsor may delay publication up to 180 days to permit the filing of appropriate patent applications if the sponsor believes any publication contains any information relating to patentable items and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER