Trial Outcomes & Findings for LEGION™ Primary Safety and Efficacy (NCT NCT04040985)

NCT ID: NCT04040985

Last Updated: 2024-10-10

Results Overview

Kaplan-Meier (KM) implant survivorship where survivorship defined as percentage of knees where no revision was required for any reason through 120 months

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

128 participants

Primary outcome timeframe

Postoperatively through 120 months

Results posted on

2024-10-10

Participant Flow

Unit of analysis: knees

Participant milestones

Participant milestones
Measure	LEGION™ Primary LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Overall Study STARTED	128 138
Overall Study COMPLETED	69 77
Overall Study NOT COMPLETED	59 61

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LEGION™ Primary Safety and Efficacy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEGION™ Primary n=138 knees LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Age, Continuous	66.2 years STANDARD_DEVIATION 8.45 • n=128 Participants
Age, Customized Age Group · ≤ 60 years	34 knees n=138 knees
Age, Customized Age Group · > 60 years	104 knees n=138 knees
Sex: Female, Male Female	89 knees n=138 knees
Sex: Female, Male Male	49 knees n=138 knees
Region of Enrollment United States	128 Participants n=128 Participants
Body Mass Index (BMI)	31.1 kg/m^2 STANDARD_DEVIATION 6.06 • n=128 Participants
Knee side implanted with device Left	69 knees n=138 knees
Knee side implanted with device Right	69 knees n=138 knees

PRIMARY outcome

Timeframe: Postoperatively through 120 months

Population: The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated.

Kaplan-Meier (KM) implant survivorship where survivorship defined as percentage of knees where no revision was required for any reason through 120 months

Outcome measures

Outcome measures
Measure	LEGION™ Primary n=77 knees LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Implant Survivorship Percentage	96.9 percentage of knees Interval 93.4 to 100.0

SECONDARY outcome

Timeframe: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

Population: The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent.

The Knee Society Score (KSS) performance outcome comprised information on objective knee indicators related to everyday activities. The Performance Score ranged from 0 to 100 with a higher score indicating a better outcome.

Outcome measures

Outcome measures
Measure	LEGION™ Primary n=135 knees LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Knee Society Score (KSS) - Performance Preoperative	40.9 score on a scale Standard Deviation 15.5
Knee Society Score (KSS) - Performance 3 months	84.5 score on a scale Standard Deviation 15.8
Knee Society Score (KSS) - Performance 12 months	94.2 score on a scale Standard Deviation 10.0
Knee Society Score (KSS) - Performance 24 months	95.1 score on a scale Standard Deviation 9.0
Knee Society Score (KSS) - Performance 36 months	96.5 score on a scale Standard Deviation 5.8
Knee Society Score (KSS) - Performance 60 months	97.4 score on a scale Standard Deviation 5.6
Knee Society Score (KSS) - Performance 84 months	94.4 score on a scale Standard Deviation 10.0
Knee Society Score (KSS) - Performance 120 months	98.0 score on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

Population: The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent.

The Knee Society Score (KSS) function outcome comprised information on functional knee indicators related to walking \& standing, standard activities, advanced activities, and discretionary activities. The Function Score ranged from 0 to 100 with a higher score indicating a better outcome.

Outcome measures

Outcome measures
Measure	LEGION™ Primary n=136 knees LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Knee Society Score (KSS) - Function Preoperative	53.8 score on a scale Standard Deviation 15.8
Knee Society Score (KSS) - Function 3 months	73.1 score on a scale Standard Deviation 18.2
Knee Society Score (KSS) - Function 12 months	88.1 score on a scale Standard Deviation 14.8
Knee Society Score (KSS) - Function 24 months	91.0 score on a scale Standard Deviation 14.5
Knee Society Score (KSS) - Function 36 months	90.4 score on a scale Standard Deviation 16.7
Knee Society Score (KSS) - Function 60 months	93.4 score on a scale Standard Deviation 12.6
Knee Society Score (KSS) - Function 84 months	87.9 score on a scale Standard Deviation 16.1
Knee Society Score (KSS) - Function 120 months	89.3 score on a scale Standard Deviation 13.8

SECONDARY outcome

Timeframe: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

Population: The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent.

The Knee Osteoarthritis Outcome Score (KOOS) Pain subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.

Outcome measures

Outcome measures
Measure	LEGION™ Primary n=136 knees LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Knee Osteoarthritis Outcome Score (KOOS) - Pain Preoperative	43.0 score on a scale Standard Deviation 17.0
Knee Osteoarthritis Outcome Score (KOOS) - Pain 3 months	72.4 score on a scale Standard Deviation 16.7
Knee Osteoarthritis Outcome Score (KOOS) - Pain 12 months	88.6 score on a scale Standard Deviation 13.9
Knee Osteoarthritis Outcome Score (KOOS) - Pain 24 months	90.9 score on a scale Standard Deviation 13.1
Knee Osteoarthritis Outcome Score (KOOS) - Pain 36 months	92.5 score on a scale Standard Deviation 10.2
Knee Osteoarthritis Outcome Score (KOOS) - Pain 60 months	94.2 score on a scale Standard Deviation 8.4
Knee Osteoarthritis Outcome Score (KOOS) - Pain 84 months	93.1 score on a scale Standard Deviation 11.9
Knee Osteoarthritis Outcome Score (KOOS) - Pain 120 months	95.7 score on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

Population: The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent.

The Knee Osteoarthritis Outcome Score (KOOS) Symptom subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.

Outcome measures

Outcome measures
Measure	LEGION™ Primary n=136 knees LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Knee Osteoarthritis Outcome Score (KOOS) - Symptom Preoperative	46.6 score on a scale Standard Deviation 20.2
Knee Osteoarthritis Outcome Score (KOOS) - Symptom 3 months	68.5 score on a scale Standard Deviation 15.5
Knee Osteoarthritis Outcome Score (KOOS) - Symptom 12 months	83.3 score on a scale Standard Deviation 11.6
Knee Osteoarthritis Outcome Score (KOOS) - Symptom 24 months	85.9 score on a scale Standard Deviation 13.1
Knee Osteoarthritis Outcome Score (KOOS) - Symptom 36 months	88.4 score on a scale Standard Deviation 11.2
Knee Osteoarthritis Outcome Score (KOOS) - Symptom 60 months	89.1 score on a scale Standard Deviation 9.7
Knee Osteoarthritis Outcome Score (KOOS) - Symptom 84 months	90.9 score on a scale Standard Deviation 9.5
Knee Osteoarthritis Outcome Score (KOOS) - Symptom 120 months	91.9 score on a scale Standard Deviation 10.0

SECONDARY outcome

Timeframe: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

Population: The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent.

The Knee Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.

Outcome measures

Outcome measures
Measure	LEGION™ Primary n=136 knees LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL) Preoperative	46.4 score on a scale Standard Deviation 18.1
Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL) 3 months	77.5 score on a scale Standard Deviation 15.2
Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL) 12 months	88.3 score on a scale Standard Deviation 11.4
Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL) 24 months	90.1 score on a scale Standard Deviation 12.5
Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL) 36 months	93.0 score on a scale Standard Deviation 9.5
Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL) 60 months	92.4 score on a scale Standard Deviation 9.6
Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL) 84 months	91.8 score on a scale Standard Deviation 12.2
Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL) 120 months	92.2 score on a scale Standard Deviation 12.5

SECONDARY outcome

Timeframe: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

Population: The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent.

The Knee Osteoarthritis Outcome Score (KOOS) Sports and Recreational Activities subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.

Outcome measures

Outcome measures
Measure	LEGION™ Primary n=125 knees LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities Preoperative	17.0 score on a scale Standard Deviation 23.4
Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities 3 months	49.1 score on a scale Standard Deviation 32.9
Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities 12 months	66.7 score on a scale Standard Deviation 28.4
Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities 24 months	67.5 score on a scale Standard Deviation 28.7
Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities 36 months	76.1 score on a scale Standard Deviation 27.9
Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities 60 months	71.0 score on a scale Standard Deviation 30.5
Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities 84 months	69.5 score on a scale Standard Deviation 32.5
Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities 120 months	71.3 score on a scale Standard Deviation 33.5

SECONDARY outcome

Timeframe: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

Population: The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent.

The Knee Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.

Outcome measures

Outcome measures
Measure	LEGION™ Primary n=136 knees LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL) Preoperative	17.6 score on a scale Standard Deviation 15.7
Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL) 3 months	56.4 score on a scale Standard Deviation 21.9
Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL) 12 months	76.5 score on a scale Standard Deviation 20.0
Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL) 24 months	78.8 score on a scale Standard Deviation 20.3
Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL) 36 months	82.8 score on a scale Standard Deviation 18.4
Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL) 60 months	84.3 score on a scale Standard Deviation 18.7
Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL) 84 months	82.5 score on a scale Standard Deviation 19.5
Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL) 120 months	85.9 score on a scale Standard Deviation 18.7

SECONDARY outcome

Timeframe: Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years

Population: The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated.

Performed weight bearing AP and lateral standard x-rays to identify knees with presence or absence of radiolucent lines categorized as: * Findings in Femoral Zone * Findings in Tibial Mediolateral (ML) Zone * Findings in Tibial Anteroposterior (AP) Zone * Findings in Patella Zone * No Radiolucent Lines Found

Outcome measures

Outcome measures
Measure	LEGION™ Primary n=138 knees LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Radiographic Evaluation - Radiolucent Lines Discharge · Findings in Femoral Zone	0 knees
Radiographic Evaluation - Radiolucent Lines Discharge · Findings in Tibial ML Zone	0 knees
Radiographic Evaluation - Radiolucent Lines Discharge · Findings in Tibial AP Zone	0 knees
Radiographic Evaluation - Radiolucent Lines Discharge · Findings in Patella Zone	0 knees
Radiographic Evaluation - Radiolucent Lines Discharge · No Radiolucent Lines Found	138 knees
Radiographic Evaluation - Radiolucent Lines 3 months · Findings in Femoral Zone	1 knees
Radiographic Evaluation - Radiolucent Lines 3 months · Findings in Tibial ML Zone	0 knees
Radiographic Evaluation - Radiolucent Lines 3 months · Findings in Tibial AP Zone	1 knees
Radiographic Evaluation - Radiolucent Lines 3 months · Findings in Patella Zone	0 knees
Radiographic Evaluation - Radiolucent Lines 3 months · No Radiolucent Lines Found	134 knees
Radiographic Evaluation - Radiolucent Lines 1 year · Findings in Femoral Zone	0 knees
Radiographic Evaluation - Radiolucent Lines 1 year · Findings in Tibial ML Zone	0 knees
Radiographic Evaluation - Radiolucent Lines 1 year · Findings in Tibial AP Zone	4 knees
Radiographic Evaluation - Radiolucent Lines 1 year · Findings in Patella Zone	0 knees
Radiographic Evaluation - Radiolucent Lines 1 year · No Radiolucent Lines Found	128 knees
Radiographic Evaluation - Radiolucent Lines 2 years · Findings in Femoral Zone	1 knees
Radiographic Evaluation - Radiolucent Lines 2 years · Findings in Tibial ML Zone	2 knees
Radiographic Evaluation - Radiolucent Lines 2 years · Findings in Tibial AP Zone	4 knees
Radiographic Evaluation - Radiolucent Lines 2 years · Findings in Patella Zone	1 knees
Radiographic Evaluation - Radiolucent Lines 2 years · No Radiolucent Lines Found	111 knees
Radiographic Evaluation - Radiolucent Lines 3 years · Findings in Femoral Zone	2 knees
Radiographic Evaluation - Radiolucent Lines 3 years · Findings in Tibial ML Zone	3 knees
Radiographic Evaluation - Radiolucent Lines 3 years · Findings in Tibial AP Zone	2 knees
Radiographic Evaluation - Radiolucent Lines 3 years · Findings in Patella Zone	1 knees
Radiographic Evaluation - Radiolucent Lines 3 years · No Radiolucent Lines Found	104 knees
Radiographic Evaluation - Radiolucent Lines 5 years · Findings in Femoral Zone	2 knees
Radiographic Evaluation - Radiolucent Lines 5 years · Findings in Tibial ML Zone	2 knees
Radiographic Evaluation - Radiolucent Lines 5 years · Findings in Tibial AP Zone	2 knees
Radiographic Evaluation - Radiolucent Lines 5 years · Findings in Patella Zone	3 knees
Radiographic Evaluation - Radiolucent Lines 5 years · No Radiolucent Lines Found	94 knees
Radiographic Evaluation - Radiolucent Lines 7 years · Findings in Femoral Zone	2 knees
Radiographic Evaluation - Radiolucent Lines 7 years · Findings in Tibial ML Zone	3 knees
Radiographic Evaluation - Radiolucent Lines 7 years · Findings in Tibial AP Zone	2 knees
Radiographic Evaluation - Radiolucent Lines 7 years · Findings in Patella Zone	3 knees
Radiographic Evaluation - Radiolucent Lines 7 years · No Radiolucent Lines Found	74 knees
Radiographic Evaluation - Radiolucent Lines 10 years · Findings in Femoral Zone	0 knees
Radiographic Evaluation - Radiolucent Lines 10 years · Findings in Tibial ML Zone	0 knees
Radiographic Evaluation - Radiolucent Lines 10 years · Findings in Tibial AP Zone	0 knees
Radiographic Evaluation - Radiolucent Lines 10 years · Findings in Patella Zone	2 knees
Radiographic Evaluation - Radiolucent Lines 10 years · No Radiolucent Lines Found	74 knees

SECONDARY outcome

Timeframe: Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years

Population: The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated.

Performed weight bearing AP and lateral standard x-rays to identify knees that observed periosteal hypertrophy, implant loosening, osteolysis or subsidence (Yes/No).

Outcome measures

Outcome measures
Measure	LEGION™ Primary n=138 knees LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence Discharge · Yes	0 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence Discharge · No	138 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 3 months · Yes	1 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 3 months · No	135 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 1 year · Yes	0 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 1 year · No	132 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 2 years · Yes	0 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 2 years · No	119 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 3 years · Yes	0 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 3 years · No	112 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 5 years · Yes	2 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 5 years · No	101 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 7 years · Yes	2 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 7 years · No	82 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 10 years · Yes	2 knees
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence 10 years · No	74 knees

SECONDARY outcome

Timeframe: Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years

Population: The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated.

Performed weight bearing AP and lateral standard x-rays to identify knees that observed patellar problems (Yes/No).

Outcome measures

Outcome measures
Measure	LEGION™ Primary n=138 knees LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Radiographic Evaluation - Observed Patellar Problem Discharge · Yes	0 knees
Radiographic Evaluation - Observed Patellar Problem Discharge · No	138 knees
Radiographic Evaluation - Observed Patellar Problem 3 months · Yes	0 knees
Radiographic Evaluation - Observed Patellar Problem 1 year · Yes	0 knees
Radiographic Evaluation - Observed Patellar Problem 1 year · No	132 knees
Radiographic Evaluation - Observed Patellar Problem 2 years · Yes	1 knees
Radiographic Evaluation - Observed Patellar Problem 2 years · No	118 knees
Radiographic Evaluation - Observed Patellar Problem 3 years · Yes	3 knees
Radiographic Evaluation - Observed Patellar Problem 3 years · No	109 knees
Radiographic Evaluation - Observed Patellar Problem 5 years · Yes	0 knees
Radiographic Evaluation - Observed Patellar Problem 5 years · No	103 knees
Radiographic Evaluation - Observed Patellar Problem 7 years · Yes	1 knees
Radiographic Evaluation - Observed Patellar Problem 7 years · No	83 knees
Radiographic Evaluation - Observed Patellar Problem 10 years · Yes	0 knees
Radiographic Evaluation - Observed Patellar Problem 10 years · No	76 knees
Radiographic Evaluation - Observed Patellar Problem 3 months · No	136 knees

Adverse Events

LEGION™ Primary

Serious events: 75 serious events

Other events: 116 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	LEGION™ Primary n=128 participants at risk LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Metabolism and nutrition disorders Anemic	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Ankle fracture	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Back surgery, due to lumbar spondylosis	2.3% 3/128 • Number of events 3 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Infections and infestations Buttock abcess	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Cardiac disorders Cardiac stent for heart disease, bigemy	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Chronic rotator cuff tear	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Compression fracture, lower back, due to degeneration lumbar disc	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Compression fracture, lower back	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Compression fracture	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Cardiac disorders Death - cardiac event	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Death - Parkinson's Disease	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
General disorders Death - Unknown cause	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Vascular disorders Deep vein thrombosis, calf	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Vascular disorders Deep vein thrombosis, lower extremity	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Vascular disorders Deep vein thrombosis, popliteal vein	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Vascular disorders Deep vein thrombosis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Metabolism and nutrition disorders Diabetes Mellitus	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Gastrointestinal disorders Erosive esophagitis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Foot navicular stress fracture	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Injury, poisoning and procedural complications Fracture after component insertion and cementing	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Hip fracture with bipolar hemiarthroplasty and knee contusion	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Hip osteoarthritis	3.1% 4/128 • Number of events 4 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Hip pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Endocrine disorders Hyperparathyroidism	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Cardiac disorders Hypertension	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Cardiac disorders Hypotension	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Injury, poisoning and procedural complications Infected total knee	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Infections and infestations Infection	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee arthrofibrosis	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee effusion	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Surgical and medical procedures Knee lateral retinacular release	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee manipulation under anesthesia, due to arthrofibrosis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee manipulation under anesthesia, due to stiffness	2.3% 3/128 • Number of events 3 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Surgical and medical procedures Knee manipulation under anesthesia	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee osteoarthritis	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee patellar tendonitis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee stiffness	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Surgical and medical procedures Lap band procedure	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
General disorders Leg swelling	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer, stage III	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Product Issues Mechanical loosening of internal knee patella button	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Cardiac disorders Myocardial infarction	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Olecranon and distal radius fracture	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Product Issues Patellar clunking	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Radial head fracture	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Respiratory, thoracic and mediastinal disorders Respiratory failure, altered mental status and atelactasis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Shoulder arthoscopy, due to torn rotator cuff	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Spine and ribs fracture	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Vascular disorders Splenic artery aneurism embolisation	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Superficial wound debricence, post-op	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Total hip arthroplasty, due to hip pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Total hip arthroplasty, due to osteoarthritis	2.3% 3/128 • Number of events 3 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Surgical and medical procedures Total hip arthroplasty	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Total knee arthroplasty, due to knee pain secondary to degenerative joint disease	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Total knee arthroplasty, due to knee pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Total knee arthroplasty, due to osteoarthritis	6.2% 8/128 • Number of events 8 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Surgical and medical procedures Total knee arthroplasty	8.6% 11/128 • Number of events 11 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Renal and urinary disorders Urinary retention	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Vertebral compression fracture	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Wrist fracture	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.

Other adverse events

Other adverse events
Measure	LEGION™ Primary n=128 participants at risk LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Nervous system disorders Carpal tunnel, bilateral	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Achilles tendonitis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Metabolism and nutrition disorders Anemia	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Ankle sprain	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Ankle swelling	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Back and hip pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Back pain and SI joint stiffness	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Back pain	2.3% 3/128 • Number of events 4 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Bakers cyst	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Renal and urinary disorders Bladder control loss and pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Blisters near incision	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Vascular disorders Chronic venous insufficiency lower extremities, bilateral	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Clicking knee	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Gastrointestinal disorders Constipation	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Contusion, due to fall	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cyst anterior knee	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Degeneration of lumbar intervertebral disc and spinal stenosis	0.78% 1/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Gastrointestinal disorders Diarrhea	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Distal fibular avulsion and left wrist injury, due to fall	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
General disorders Dizziness	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Dupuytren's middle finger	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Erythema of incision	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Exostosis lateral femoral condyle knee	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
General disorders Fall	2.3% 3/128 • Number of events 3 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
General disorders Fever	2.3% 3/128 • Number of events 4 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Finger contusions	0.78% 1/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Foot and ankle pain	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Foot and ankle partial tear	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Foot neuropathy	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Foot pain, bilateral	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Foot pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Groin pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Hand pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
General disorders Headache	0.78% 1/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Heretopic ossification	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Herniated disc	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Heterotopic ossification infra patella	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Heterotopic ossification of femoral component	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Heterotopic ossification	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Hip and knee pain, due to IT band friction syndrome	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Hip pain and sciatica	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Hip pain, bilateral	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Hip pain, due to osteoarthritis and trochanteric bursitis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Hip pain, due to osteoarthritis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Hip pain, lateral	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Hip pain	2.3% 3/128 • Number of events 5 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Hypertrophic scar formation	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Metabolism and nutrition disorders Hypokalemia	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Index finder	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Index finger	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders IT band irritation	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee arthrofibrosis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Knee bakers cyst	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee buckling	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee clicking and grinding	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee clicking	3.9% 5/128 • Number of events 6 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Knee contusion, bilateral	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Knee contusion, due to fall	3.1% 4/128 • Number of events 4 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Knee contusion	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee crackling when standing	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Knee hematoma and contusion, due to fall	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Knee hematoma	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee hyperextension	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee instability	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee lateral swelling	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee lump and pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee osteoarthritis with crepitus	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee osteoarthritis	6.2% 8/128 • Number of events 8 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Knee pain and bruising, due to fall	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Knee pain with swelling and redness around patella	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee pain, bilateral	0.78% 1/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Knee pain, due to contusion	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee pain, due to fall	4.7% 6/128 • Number of events 6 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee pain, due to MVA	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee pain, due to osteoarthritis	0.78% 1/128 • Number of events 11 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee pain	10.2% 13/128 • Number of events 15 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee pes anserine bursitis	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee popping	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee posteriolateral popping, occasional	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee soft tissue pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee stiffness post manipulation	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee stiffness, post op	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee stiffness	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee strain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Infections and infestations Knee swelling, due to infection	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee swelling, intermittent	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee swelling	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee tenderness along MCL	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Knee tenderness and bruising, due to fall	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Knee tightness	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Infections and infestations Knee wound infection drainage	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Lateral knee pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Lateral patella tilt and impingment	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Lateral subluxation and patella tilt	0.78% 1/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Leg pain, due to advanced arthritic changes of lumbar spine	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Leg swelling and ecchymosis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Lower back and groin pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Lower back and hip pain	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Lower back pain and sciatica	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Lower back pain radiating to lower extremities	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Lower back pain with radiculopathy	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Lower back pain, due to degeneration of lumbar intervertebral disc, spondylosis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Lower back pain	3.9% 5/128 • Number of events 5 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Vascular disorders Lower calf clot	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Skin and subcutaneous tissue disorders Lower extremity swelling	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Lumbar pain, due to sciatica-lumbar radiculopathy	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Lumbar radiculitis and spasm	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Lumbar radiculopathy and sciatica	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Lumbar spondylosis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders MVA	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Patella heterotopic ossification	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Patella periosteal hypertrophy	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Patellar Subluxation	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Peroneal nerve palsy	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Reabsorption on the medial tibial plateau	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Sacroilliac pain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Sciatica and spasm	0.78% 1/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Sciatica	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Shoulder bursitis and osteoarthritis	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Shoulder fracture, due to fall	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Shoulder pain, bilateral	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Shoulder pain, due to impingement	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Shoulder pain, due to severe glenohumeral DJD	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Shoulder pain	3.9% 5/128 • Number of events 9 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Shoulder rotator cuff tear	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Shoulder stiffness, due to post op	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
General disorders Shuffling gait	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
General disorders Spinal stenosis and sciatica	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Spinal stenosis	2.3% 3/128 • Number of events 6 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Spondylosis and allied disorder	0.78% 1/128 • Number of events 4 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Spondylosis and sacroilliac joint inflamed	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Stenosing tenosynovitis finger	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Thumb pain, due to arthritis	0.78% 1/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Tingling anterior thigh	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Total hip, post-op	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Total shoulder, pre op	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Musculoskeletal and connective tissue disorders Trochanteric bursitis	1.6% 2/128 • Number of events 2 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Renal and urinary disorders Urinary tract infection	2.3% 3/128 • Number of events 3 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Nervous system disorders Vertigo	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
Metabolism and nutrition disorders Weakness, due to low sodium	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.
General disorders Weight gain	0.78% 1/128 • Number of events 1 • Adverse events were collected from surgery up to 10 years. Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device \& surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, \& circumstance. Thus, Investigators reported AE relatedness for device \& procedure in the same Case Report Form (CRF) question.

Additional Information

Michael Howarth

Smith and Nephew

Phone: 07540268240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60