Trial Outcomes & Findings for Comprehensive Shoulder System Nano IDE (NCT NCT01936259)

NCT ID: NCT01936259

Last Updated: 2020-01-13

Results Overview

The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.

Recruitment status

COMPLETED

Study phase

Target enrollment

258 participants

Primary outcome timeframe

22+ Months

Results posted on

2020-01-13

Participant Flow

Due to competitive enrollment, one extra shoulder was randomized and enrolled into the study in the Control group as the site was not aware the study had reached full enrollment. 258 individual subjects were enrolled in the study. 7 subjects underwent study procedures bilaterally, resulting in 265 shoulders enrolled in the study.

Subjects were randomized 1:1 to either the Comprehensive Shoulder System with Nano Humeral Component (Investigational) or the Comprehensive Shoulder System with Mini Humeral Stem (Control). Treatment assignments occurred intraoperatively and subjects remained blinded until completion of two-year follow-up for all subjects.

Unit of analysis: Shoulders

Participant milestones

Participant milestones
Measure	Comprehensive Mini Humeral Stem This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).	Comprehensive Nano Humeral Component This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
Overall Study STARTED	130 133	131 132
Overall Study COMPLETED	118 121	111 112
Overall Study NOT COMPLETED	12 12	20 20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comprehensive Shoulder System Nano IDE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Comprehensive Mini Humeral Stem n=133 Shoulders This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).	Comprehensive Nano Humeral Component n=132 Shoulders This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).	Total n=265 Shoulders Total of all reporting groups
Age, Continuous	62.1 Years STANDARD_DEVIATION 9.6 • n=133 Shoulders	63.1 Years STANDARD_DEVIATION 9.0 • n=132 Shoulders	62.6 Years STANDARD_DEVIATION 9.3 • n=265 Shoulders
Sex: Female, Male Female	46 Shoulders n=133 Shoulders	43 Shoulders n=132 Shoulders	89 Shoulders n=265 Shoulders
Sex: Female, Male Male	87 Shoulders n=133 Shoulders	89 Shoulders n=132 Shoulders	176 Shoulders n=265 Shoulders
Race/Ethnicity, Customized African American	6 Shoulders n=133 Shoulders	4 Shoulders n=132 Shoulders	10 Shoulders n=265 Shoulders
Race/Ethnicity, Customized Asian	0 Shoulders n=133 Shoulders	1 Shoulders n=132 Shoulders	1 Shoulders n=265 Shoulders
Race/Ethnicity, Customized Caucasian	125 Shoulders n=133 Shoulders	126 Shoulders n=132 Shoulders	251 Shoulders n=265 Shoulders
Race/Ethnicity, Customized Hispanic or Latino	2 Shoulders n=133 Shoulders	1 Shoulders n=132 Shoulders	3 Shoulders n=265 Shoulders
Region of Enrollment United States	133 Shoulders n=133 Shoulders	132 Shoulders n=132 Shoulders	265 Shoulders n=265 Shoulders
Procedure on Unilateral/Bilateral Patient Bilateral	9 Shoulders n=133 Shoulders	5 Shoulders n=132 Shoulders	14 Shoulders n=265 Shoulders
Procedure on Unilateral/Bilateral Patient Unilateral	124 Shoulders n=133 Shoulders	127 Shoulders n=132 Shoulders	251 Shoulders n=265 Shoulders

PRIMARY outcome

Timeframe: 22+ Months

Population: All subjects with ASES data available at the two year visit were assessed.

Outcome measures

Outcome measures
Measure	Comprehensive Mini Humeral Stem n=121 Shoulders This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).	Comprehensive Nano Humeral Component n=112 Shoulders This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
American Shoulder and Elbow Surgeon's Score (ASES)	92.20 score on a scale Standard Deviation 13.51	92.47 score on a scale Standard Deviation 14.94

PRIMARY outcome

Timeframe: 2 years

Population: The total number of cases for each group includes all subjects with two year data, plus all subjects considered failures without two year data.

This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "No unanticipated device-related adverse event, and no fracture, perforation of the bone or joint dislocation, and no fracture, perforation or dissociation of the device, and no revision or removal of any component." All subject records were evaluated for each of the disqualifying factors, and all subjects that failed at least one of the endpoint measures were identified. The success rate is defined as the number of subjects at two years not meeting any of the disqualifying factors compared to the total number of cases present at two years plus all subjects considered failures without two year data.

Outcome measures

Outcome measures
Measure	Comprehensive Mini Humeral Stem n=123 Shoulders This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).	Comprehensive Nano Humeral Component n=116 Shoulders This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation Success Shoulders	114 Shoulders	107 Shoulders
Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation Failure Shoulders	9 Shoulders	9 Shoulders

PRIMARY outcome

Timeframe: 2 years

Population: All subjects at each time point were evaluated for radiographic success based on these criteria.

This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "Subsidence of the humeral component \<5 mm, and migration of the humeral component \<5 mm, and no progressive lucency around the humeral component \>2 mm in two or more contiguous zones, and migration of the glenoid component \<5 mm, and no progressive lucency \>2 mm around the entire glenoid component." All subject records were evaluated by an Independent Radiographic Reviewer (IRR) at each time point for radiographic success based on these criteria.

Outcome measures

Outcome measures
Measure	Comprehensive Mini Humeral Stem n=133 Shoulders This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).	Comprehensive Nano Humeral Component n=132 Shoulders This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
Number of Shoulders With Radiographic Success Success Shoulders	133 Shoulders	132 Shoulders
Number of Shoulders With Radiographic Success Failure Shoulders	0 Shoulders	0 Shoulders

SECONDARY outcome

Timeframe: Pre-operative, 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years

Population: All subjects with an ASES score collected at each specified study time period were assessed.

Outcome measures

Outcome measures
Measure	Comprehensive Mini Humeral Stem n=133 Shoulders This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).	Comprehensive Nano Humeral Component n=132 Shoulders This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
American Shoulder and Elbow Surgeon's Score (ASES) Pre-operative	25.8 score on a scale Standard Deviation 9.6	25.1 score on a scale Standard Deviation 10.7
American Shoulder and Elbow Surgeon's Score (ASES) 6 Weeks	60.1 score on a scale Standard Deviation 18.3	61.5 score on a scale Standard Deviation 17.4
American Shoulder and Elbow Surgeon's Score (ASES) 3 Months	80.2 score on a scale Standard Deviation 16.4	80.5 score on a scale Standard Deviation 15.3
American Shoulder and Elbow Surgeon's Score (ASES) 1 Year	91.2 score on a scale Standard Deviation 12.8	92.8 score on a scale Standard Deviation 12.2
American Shoulder and Elbow Surgeon's Score (ASES) 2 Years	92.2 score on a scale Standard Deviation 13.5	92.5 score on a scale Standard Deviation 14.9
American Shoulder and Elbow Surgeon's Score (ASES) 3 Years	95.0 score on a scale Standard Deviation 9.8	90.0 score on a scale Standard Deviation 17.8
American Shoulder and Elbow Surgeon's Score (ASES) 4 Years	95.1 score on a scale Standard Deviation 6.4	94.3 score on a scale Standard Deviation 11.3

SECONDARY outcome

Timeframe: 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years

Population: All subjects with a SANE score collected at each specified study time period were assessed.

The Single Assessment Numeric Evaluation (SANE) Score is a tool used to assess the subject's perception of their affected joint. Participants are requested to rate their shoulder function on a scale of 0 to 100, with 0 as the worst option and 100 being normal shoulder function.

Outcome measures

Outcome measures
Measure	Comprehensive Mini Humeral Stem n=133 Shoulders This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).	Comprehensive Nano Humeral Component n=132 Shoulders This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
Single Assessment Numeric Evaluation (SANE) Score 6 Weeks	55.7 score on a scale Standard Deviation 24.2	53.7 score on a scale Standard Deviation 23.9
Single Assessment Numeric Evaluation (SANE) Score 3 Months	80.4 score on a scale Standard Deviation 14.9	80.7 score on a scale Standard Deviation 16.1
Single Assessment Numeric Evaluation (SANE) Score 1 Year	90.4 score on a scale Standard Deviation 12.2	92.2 score on a scale Standard Deviation 9.3
Single Assessment Numeric Evaluation (SANE) Score 2 Years	92.3 score on a scale Standard Deviation 11.9	92.3 score on a scale Standard Deviation 14.5
Single Assessment Numeric Evaluation (SANE) Score 3 Years	94.7 score on a scale Standard Deviation 6.9	91.5 score on a scale Standard Deviation 15.5
Single Assessment Numeric Evaluation (SANE) Score 4 Years	93.4 score on a scale Standard Deviation 7.0	93.0 score on a scale Standard Deviation 12.9

SECONDARY outcome

Timeframe: Pre-operative, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years

Population: All subjects with a Constant score collected at each specified study time period were assessed. The score was not collected at 6 weeks to protect the subscapularis repair.

The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function. The age- and gender-adjusted Constant score normalizes the raw Constant score based on the subject's age and gender. The worst score on the adjusted scale is still 0, but the greatest scores can exceed 100 based on the calculations used for normalization. The scale used in this study was described by Katolik et al.

Outcome measures

Outcome measures
Measure	Comprehensive Mini Humeral Stem n=133 Shoulders This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).	Comprehensive Nano Humeral Component n=132 Shoulders This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
Constant Score Adjusted for Age and Gender Pre-operative	47.2 score on a scale Standard Deviation 17.1	46.3 score on a scale Standard Deviation 17.1
Constant Score Adjusted for Age and Gender 3 Months	82.6 score on a scale Standard Deviation 18.8	83.1 score on a scale Standard Deviation 19.1
Constant Score Adjusted for Age and Gender 1 Year	97.9 score on a scale Standard Deviation 16.8	99.8 score on a scale Standard Deviation 14.9
Constant Score Adjusted for Age and Gender 2 Years	100.2 score on a scale Standard Deviation 15.0	101.5 score on a scale Standard Deviation 16.7
Constant Score Adjusted for Age and Gender 3 Years	100.2 score on a scale Standard Deviation 14.4	99.2 score on a scale Standard Deviation 17.3
Constant Score Adjusted for Age and Gender 4 Years	98.0 score on a scale Standard Deviation 12.0	103.5 score on a scale Standard Deviation 15.6

SECONDARY outcome

Timeframe: 2+ years

Population: All subject radiographs at all time points that were submitted to the Independent Radiographic Reviewer were analyzed.

All radiographs collected at all follow-up time points were analyzed by the Independent Radiographic reviewer. Subjects were assessed for the presence of radiolucencies considered to be failures of the radiographic co-primary endpoint (No progressive lucency around the humeral component \>2 mm in two or more contiguous zones OR no progressive lucency \>2 mm around the entire glenoid component) and for the presence of component subsidence. Subjects with the absence of failing radiolucencies and subsidence were considered successes.

Outcome measures

Outcome measures
Measure	Comprehensive Mini Humeral Stem n=133 Shoulders This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).	Comprehensive Nano Humeral Component n=132 Shoulders This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence Success Shoulders	133 Shoulders	132 Shoulders
Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence Failure Shoulders	0 Shoulders	0 Shoulders

Adverse Events

Comprehensive Mini Humeral Stem

Serious events: 55 serious events

Other events: 118 other events

Deaths: 2 deaths

Comprehensive Nano Humeral Component

Serious events: 41 serious events

Other events: 105 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Comprehensive Mini Humeral Stem n=130 participants at risk This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).	Comprehensive Nano Humeral Component n=131 participants at risk This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
Cardiac disorders Cardiac Arrhythmia	0.77% 1/130 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.76% 1/131 • Number of events 2 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
General disorders Death (Non-Shoulder Related)	1.5% 2/130 • Number of events 2 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	2.3% 3/131 • Number of events 3 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Infections and infestations Infection	1.5% 2/130 • Number of events 2 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.76% 1/131 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Cardiac disorders Myocardial Infarction	1.5% 2/130 • Number of events 2 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.00% 0/131 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Vascular disorders Pulmonary Embolism	1.5% 2/130 • Number of events 2 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.00% 0/131 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Respiratory, thoracic and mediastinal disorders Respiratory Infection	0.00% 0/130 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.76% 1/131 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Vascular disorders Stroke	0.77% 1/130 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.76% 1/131 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
General disorders Other General (Non-Shoulder Related) Complication	33.8% 44/130 • Number of events 62 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	26.7% 35/131 • Number of events 49 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Musculoskeletal and connective tissue disorders Dislocation / Subluxation	0.77% 1/130 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.00% 0/131 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Surgical and medical procedures Implant or Part Failure or Fracture	0.77% 1/130 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.00% 0/131 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Musculoskeletal and connective tissue disorders Other Shoulder-Related Complication	4.6% 6/130 • Number of events 6 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	3.1% 4/131 • Number of events 4 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.

Other adverse events

Additional Information

Director of Clinical Operations

Zimmer Biomet, Inc.

Phone: 800-613-6131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Investigator must provide the Sponsor with at least 30 days to review publications for legal and regulatory compliance and will include in publications a statement that the study was supported by the Sponsor. Sponsor confidential information will not be submitted for publication without Sponsor consent. Sponsor may request delay of publication for 60 days to allow for patent application filing.
Publication restrictions are in place

Restriction type: OTHER

Measure	Comprehensive Mini Humeral Stem n=130 participants at risk This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).	Comprehensive Nano Humeral Component n=131 participants at risk This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
Cardiac disorders Cardiac Arrhythmia	1.5% 2/130 • Number of events 3 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	1.5% 2/131 • Number of events 3 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Gastrointestinal disorders Gastrointestinal Bleeding	0.77% 1/130 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.00% 0/131 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Infections and infestations Infection	1.5% 2/130 • Number of events 2 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.76% 1/131 • Number of events 2 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Nervous system disorders Nerve Injury	1.5% 2/130 • Number of events 2 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	2.3% 3/131 • Number of events 3 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Respiratory, thoracic and mediastinal disorders Respiratory Infection	0.77% 1/130 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.00% 0/131 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Renal and urinary disorders Urinary Retention	0.00% 0/130 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.76% 1/131 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Renal and urinary disorders Urinary Tract Infection	0.77% 1/130 • Number of events 2 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.00% 0/131 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
General disorders Other General (Non-Shoulder Related) Complication	67.7% 88/130 • Number of events 193 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	55.0% 72/131 • Number of events 130 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Musculoskeletal and connective tissue disorders Instability	0.77% 1/130 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	1.5% 2/131 • Number of events 2 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Skin and subcutaneous tissue disorders Delayed Wound Healing	0.00% 0/130 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.76% 1/131 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Musculoskeletal and connective tissue disorders Dislocation / Subluxation	1.5% 2/130 • Number of events 2 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	2.3% 3/131 • Number of events 3 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Skin and subcutaneous tissue disorders Hematoma	3.8% 5/130 • Number of events 5 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	6.1% 8/131 • Number of events 8 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Surgical and medical procedures Humeral Fracture or Perforation	0.77% 1/130 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.00% 0/131 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Surgical and medical procedures Implant or Part Failure or Fracture	0.77% 1/130 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.00% 0/131 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Musculoskeletal and connective tissue disorders Inadequate Range of Motion	4.6% 6/130 • Number of events 6 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	3.8% 5/131 • Number of events 5 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Surgical and medical procedures Loosening or Migration of Implants or Parts	0.77% 1/130 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.00% 0/131 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Nervous system disorders Nerve Deficit	0.00% 0/130 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	0.76% 1/131 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Musculoskeletal and connective tissue disorders Unusual Shoulder Pain	22.3% 29/130 • Number of events 35 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	13.7% 18/131 • Number of events 23 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Skin and subcutaneous tissue disorders Wound Problems: Dehiscence, Necrosis, Drainage, Superficial Infection	0.77% 1/130 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	2.3% 3/131 • Number of events 3 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Musculoskeletal and connective tissue disorders Other Shoulder-Related Complication	44.6% 58/130 • Number of events 95 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.	39.7% 52/131 • Number of events 88 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.