Trial Outcomes & Findings for GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study (NCT NCT03168672)

NCT ID: NCT03168672

Last Updated: 2025-08-05

Results Overview

Percentage of participants with overall composite clinical success at 24 months was reported. Composite success was achieved if each of the following criteria was met: (1) Radiographs indicated that there was no continuous radiolucent line (RLL) around the GLOBAL ICON stemless humeral component, with continuous RLL defined as a radiolucent line greater than (\>) 1millimeter (mm) in all five zones of either anterior-posterior (AP) or Axillary views (2) The adjusted Constant-Murley score was greater than 85, with the adjustment based on the method of Constant (3) No GLOBAL ICON humeral component was removed for any reason (4) There was no device-related serious adverse events.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 171 participants
• Primary outcome timeframe: At 24 months
• Results posted on: 2025-08-05

Participant Flow

Patients were selected for recruitment into the study from the general diagnosis population defined as total shoulder arthroplasty (TSA). The investigation was conducted at 12 centers.

Unit of analysis: Shoulders

Participant milestones

Measure	GLOBAL ICON Stemless Shoulder System Study participants who received a GLOBAL ICON Stemless shoulder system.
Overall Study STARTED	171 172
Overall Study Safety Population	156 157
Overall Study Treated With GLOBAL ICON	156 157
Overall Study COMPLETED	0 0
Overall Study NOT COMPLETED	171 172

Reasons for withdrawal

Measure	GLOBAL ICON Stemless Shoulder System Study participants who received a GLOBAL ICON Stemless shoulder system.
Overall Study Withdrawal by Subject	13
Overall Study Death	3
Overall Study Investigator's Decision	137
Overall Study Adverse Event	1
Overall Study Other	2
Overall Study Started but not treated with GLOBAL ICON	15

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	GLOBAL ICON Stemless Shoulder System n=156 Participants Study participants who received a GLOBAL ICON Stemless shoulder system
Age, Continuous Study participant age (mean)	66.0 Years STANDARD_DEVIATION 9.04 • n=156 Participants
Sex: Female, Male Gender of study participants · Female	80 Participants n=156 Participants
Sex: Female, Male Gender of study participants · Male	76 Participants n=156 Participants

PRIMARY outcome

Timeframe: At 24 months

Population: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.

Percentage of participants with overall composite clinical success at 24 months was reported. Composite success was achieved if each of the following criteria was met: (1) Radiographs indicated that there was no continuous radiolucent line (RLL) around the GLOBAL ICON stemless humeral component, with continuous RLL defined as a radiolucent line greater than (>) 1millimeter (mm) in all five zones of either anterior-posterior (AP) or Axillary views (2) The adjusted Constant-Murley score was greater than 85, with the adjustment based on the method of Constant (3) No GLOBAL ICON humeral component was removed for any reason (4) There was no device-related serious adverse events.

Outcome measures

Measure	GLOBAL ICON Stemless Shoulder System n=140 Participants Study participants who received a GLOBAL ICON Stemless shoulder system.
Percentage of Participants With Overall Composite Clinical Success	82.86 Percentage of participants

PRIMARY outcome

Timeframe: 24 Months

Population: Study participants who received a GLOBAL ICON Shoulder system.

Constant-Murley Score on operative shoulder adjusted for gender and age. Please note that scores are adjusted to reflect gender and age of participants. The Constant-Murley score is divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100) Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male participant is 0-178.6; the range for the Adjusted Constant-Murley score in a female participant is 0-192.3. Please note the calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants.

Outcome measures

Measure	GLOBAL ICON Stemless Shoulder System n=138 Implants Study participants who received a GLOBAL ICON Stemless shoulder system.
Adjusted Constant-Murley Shoulder Assessment Score	103.7 Units on a scale Standard Deviation 21.8

PRIMARY outcome

Timeframe: 24 months

Population: All participants who received a GLOBAL ICON Stemless Shoulder were evaluated radiographically at 24 months for the presence of a continuous radiolucent line around the implant that was greater than 1mm wide.

X-rays are reviewed by an independent radiographic reviewer to determine if a 1 mm wide or greater, continuous radiolucent line around the entire bony border of the GLOBAL ICON Stemless Shoulder implant exists. Such a line may indicate the implant is loosening.

Outcome measures

Measure	GLOBAL ICON Stemless Shoulder System n=142 Participants Study participants who received a GLOBAL ICON Stemless shoulder system.
Continuous Radiolucent Line	0 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Study participants who received a GLOBAL ICON Shoulder System.

Kaplan Meier Survival Estimate is based upon the number of GLOBAL ICON implants remaining in the study and the number of GLOBAL ICON implants that have been revised (surgically removed from participants).

Outcome measures

Measure	GLOBAL ICON Stemless Shoulder System n=120 Implants Study participants who received a GLOBAL ICON Stemless shoulder system.
Kaplan Meier Survivorship	98.7 Percentage of implants Interval 95.0 to 99.7

PRIMARY outcome

Timeframe: 24 months

Population: Study participants who received a GLOBAL ICON shoulder system

Adverse events are any untoward health issues that occur when compared to a participant's normal health baseline. Serious adverse events include health events that have led to death or a serious deterioration in health that resulted in life threatening illness/injury, permanent impairment of a body structure, required hospitalization or required medical intervention to prevent life threatening illness/injury or permanent impairment to a body structure or function.

Outcome measures

Measure	GLOBAL ICON Stemless Shoulder System n=156 Participants Study participants who received a GLOBAL ICON Stemless shoulder system.
Device-related Serious Adverse Events	1 Participants

SECONDARY outcome

Timeframe: At Baseline (Day 0), 3, 12, 24, and 60 months

Population: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number analyzed) signifies number participants evaluable at specified time points.

Constant-Murley Score was adjusted to reflect gender and age of participants. The Constant-Murley score was divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100). Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male participant was 0-178.6; the range for the Adjusted Constant-Murley score in a female participant was 0-192.3. The calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants.

Outcome measures

Measure	GLOBAL ICON Stemless Shoulder System n=156 Participants Study participants who received a GLOBAL ICON Stemless shoulder system.
Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative Baseline	42.2 Unit on a scale Standard Deviation 22.5
Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative 3 Months	70.0 Unit on a scale Standard Deviation 23.1
Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative 12 Months	95.5 Unit on a scale Standard Deviation 22.8
Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative 24 Months	103.7 Unit on a scale Standard Deviation 21.7
Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative 60 Months	106.2 Unit on a scale Standard Deviation 21.7

SECONDARY outcome

Timeframe: At Baseline (Day 0), 3, 12, 24, and 60 months

Population: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number of participants analyzed) signifies number participants evaluable at specified time points.

The Oxford Shoulder Score (OSS) was a patient-based questionnaire used to assess shoulder pain after surgery. It consisted of 12 questionnaire items with 5 ordinal response options for each question. Each response was scored from 0 to 4 points (4 = best/least problems and 0=worst/unbearable pain). All item scores across 12 questions were summed to produce a scale of 0-48 (where a higher score reflected best/least problems).

Outcome measures

Measure	GLOBAL ICON Stemless Shoulder System n=156 Participants Study participants who received a GLOBAL ICON Stemless shoulder system.
Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative Baseline	20.6 Unit on a Scale Standard Deviation 8.2
Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative 3 Months	35.1 Unit on a Scale Standard Deviation 9.8
Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative 12 Months	41.9 Unit on a Scale Standard Deviation 7.7
Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative 24 Months	43.1 Unit on a Scale Standard Deviation 7.4
Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative 60 Months	43.5 Unit on a Scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: At Baseline (Day 0), 3, 12, 24, and 60 months

Population: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number analyzed) signifies number of participants evaluable at specified time points.

Mean EQ-5D-5L scores by dimensions at baseline, 3, 12, 24, and 60 months were reported. EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5-item index score was transformed into a utility score between 0 (worst health state) and 1 (best health state). Higher score indicated good health. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement.

Outcome measures

Measure	GLOBAL ICON Stemless Shoulder System n=156 Participants Study participants who received a GLOBAL ICON Stemless shoulder system.
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Mobility: Baseline	1.8 Unit on a Scale Standard Deviation 1.04
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Mobility: 3 Months	1.5 Unit on a Scale Standard Deviation 0.90
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Mobility: 12 Months	1.6 Unit on a Scale Standard Deviation 0.93
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Mobility: 24 Months	1.7 Unit on a Scale Standard Deviation 0.99
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Mobility: 60 Months	1.7 Unit on a Scale Standard Deviation 0.97
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Self-Care: Baseline	2.4 Unit on a Scale Standard Deviation 1.02
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Self-Care: 3 Months	1.6 Unit on a Scale Standard Deviation 0.87
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Self-Care: 12 Months	1.3 Unit on a Scale Standard Deviation 0.61
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Self-Care: 24 Months	1.3 Unit on a Scale Standard Deviation 0.61
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Self-Care: 60 Months	1.3 Unit on a Scale Standard Deviation 0.67
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Usual Activities: Baseline	3.0 Unit on a Scale Standard Deviation 1.00
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Usual Activities: 3 Months	2.0 Unit on a Scale Standard Deviation 0.97
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Usual Activities: 12 Months	1.6 Unit on a Scale Standard Deviation 0.85
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Usual Activities: 24 Months	1.5 Unit on a Scale Standard Deviation 0.87
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Usual Activities: 60 Months	1.6 Unit on a Scale Standard Deviation 0.83
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Pain/Discomfort: Baseline	3.5 Unit on a Scale Standard Deviation 0.82
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Pain/Discomfort: 3 Months	2.2 Unit on a Scale Standard Deviation 0.80
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Pain/Discomfort: 12 Months	2.0 Unit on a Scale Standard Deviation 0.94
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Pain/Discomfort: 24 Months	1.9 Unit on a Scale Standard Deviation 0.97
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Pain/Discomfort: 60 Months	2.1 Unit on a Scale Standard Deviation 1.01
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Anxiety/Depression: Baseline	1.7 Unit on a Scale Standard Deviation 0.98
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Anxiety/Depression: 3 Months	1.4 Unit on a Scale Standard Deviation 0.76
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Anxiety/Depression: 12 Months	1.4 Unit on a Scale Standard Deviation 0.75
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Anxiety/Depression: 24 Months	1.4 Unit on a Scale Standard Deviation 0.78
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative Anxiety/Depression: 60 Months	1.3 Unit on a Scale Standard Deviation 0.66

SECONDARY outcome

Timeframe: At Baseline (Day 0), 3, 12, 24, and 60 months

Population: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number analyzed) signifies number of participants evaluable at specified time points.

EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement.

Outcome measures

Measure	GLOBAL ICON Stemless Shoulder System n=156 Participants Study participants who received a GLOBAL ICON Stemless shoulder system.
Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative Baseline	64.7 Unit on a scale Standard Deviation 21.9
Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative 3 Months	75.6 Unit on a scale Standard Deviation 15.8
Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative 12 Months	78.1 Unit on a scale Standard Deviation 17.6
Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative 24 Months	79.3 Unit on a scale Standard Deviation 16.3
Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative 60 Months	78.0 Unit on a scale Standard Deviation 17.6

SECONDARY outcome

Timeframe: Immediate post operative (0-10 Days), at 3, 12, 24, and 60 months

Population: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number analyzed) signifies number participants evaluable at specified time points.

Number of participants with radiographic evidence of aseptic loosening of the global icon stemless humeral component immediate post-operative and 3, 12, 24 and 60 months post-operative were reported. Aseptic Loosening was evaluated using all available imaging. Progressing radiolucencies and/or stress shielding indicated aseptic loosening.

Outcome measures

Measure	GLOBAL ICON Stemless Shoulder System n=156 Participants Study participants who received a GLOBAL ICON Stemless shoulder system.
Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative Immediate Post Operative	0 Participants
Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative 3 Months	0 Participants
Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative 12 Months	0 Participants
Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative 24 Months	0 Participants
Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative 60 Months	0 Participants

Adverse Events

GLOBAL ICON Stemless Shoulder System

Serious events: 75 serious events

Other events: 100 other events

Deaths: 3 deaths

Serious adverse events

Measure	GLOBAL ICON Stemless Shoulder System n=156 participants at risk Study participants who received a GLOBAL ICON Stemless shoulder system
Cardiac disorders Acute myocardial infarction	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Angina pectoris	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Atrial fibrillation	2.6% 4/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Glaucoma	0.64% 1/156 • Number of events 1 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Abdominal pain	1.9% 3/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Constipation	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Diarrhea	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Gastrointestinal polyp	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Inguinal hernia	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Rectal polyp	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Small intestinal obstruction	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Adverse drug reaction	0.64% 1/156 • Number of events 5 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Chest pain	0.64% 1/156 • Number of events 5 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Death	0.64% 1/156 • Number of events 5 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders General physical health deterioration	0.64% 1/156 • Number of events 5 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Unevaluable event	0.64% 1/156 • Number of events 5 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Hepatobiliary disorders Hepatic function abnormal	0.64% 1/156 • Number of events 1 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations COVID-19	0.64% 1/156 • Number of events 13 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Cellulitis	0.64% 1/156 • Number of events 13 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Diverticulitis	0.64% 1/156 • Number of events 13 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Infective exacerbation of bronchiectasis	0.64% 1/156 • Number of events 13 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Kidney infection	0.64% 1/156 • Number of events 13 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Labyrinthitis	0.64% 1/156 • Number of events 13 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Medical device site joint infection	0.64% 1/156 • Number of events 13 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Pneumonia	3.2% 5/156 • Number of events 13 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Sepsis	0.64% 1/156 • Number of events 13 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Urinary tract infection	1.3% 2/156 • Number of events 13 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Urosepsis	0.64% 1/156 • Number of events 13 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Wound infection	0.64% 1/156 • Number of events 13 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Cartilage injury	0.64% 1/156 • Number of events 10 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Clavicle fracture	1.3% 2/156 • Number of events 10 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Fall	1.9% 3/156 • Number of events 10 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Humerus fracture	1.3% 2/156 • Number of events 10 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Muscle strain	0.64% 1/156 • Number of events 10 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Periprosthetic fracture	0.64% 1/156 • Number of events 10 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Radius fracture	0.64% 1/156 • Number of events 10 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Rib fracture	0.64% 1/156 • Number of events 10 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Skin injury	0.64% 1/156 • Number of events 10 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Tendon rupture	0.64% 1/156 • Number of events 10 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Traumatic arthrosis	0.64% 1/156 • Number of events 10 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Traumatic fracture	0.64% 1/156 • Number of events 10 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Metabolism and nutrition disorders Hyperkalaemia	0.64% 1/156 • Number of events 1 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Arthralgia	0.64% 1/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Arthritis	1.9% 3/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Bursitis	1.9% 3/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.64% 1/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.64% 1/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Meniscal degeneration	0.64% 1/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.64% 1/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Neck pain	0.64% 1/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Osteoarthritis	25.6% 40/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Periarthritis	1.3% 2/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.64% 1/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	3.2% 5/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.64% 1/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Synovitis	0.64% 1/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Tendon disorder	0.64% 1/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Tendon pain	0.64% 1/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Tendonitis	1.3% 2/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Vertebral osteophyte	0.64% 1/156 • Number of events 57 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal gland cancer	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.3% 2/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma stage IV	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.3% 2/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Carpal tunnel syndrome	0.64% 1/156 • Number of events 3 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Haemorrhagic stroke	0.64% 1/156 • Number of events 3 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Occipital neuralgia	0.64% 1/156 • Number of events 3 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Presyncope	0.64% 1/156 • Number of events 3 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Psychiatric disorders Confusional state	0.64% 1/156 • Number of events 2 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Psychiatric disorders Delirium	0.64% 1/156 • Number of events 2 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Psychiatric disorders Suicidal ideation	0.64% 1/156 • Number of events 2 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Renal and urinary disorders Haematuria	0.64% 1/156 • Number of events 2 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Renal and urinary disorders Urinary retention	0.64% 1/156 • Number of events 2 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.9% 3/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Skin and subcutaneous tissue disorders Skin irritation	0.64% 1/156 • Number of events 1 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Social circumstances Joint prosthesis user	0.64% 1/156 • Number of events 1 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Vascular disorders Aortic stenosis	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Vascular disorders Hypotension	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Vascular disorders Peripheral artery occlusion	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Vascular disorders Varicose vein	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.

Other adverse events

Measure	GLOBAL ICON Stemless Shoulder System n=156 participants at risk Study participants who received a GLOBAL ICON Stemless shoulder system
Blood and lymphatic system disorders Anaemia	0.64% 1/156 • Number of events 2 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Blood and lymphatic system disorders Iron deficiency anaemia	0.64% 1/156 • Number of events 2 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Angina pectoris	1.3% 2/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Atrial fibrillation	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Bradycardia	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Cardiac failure	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Dilatation atrial	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Extrasystoles	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Heart valve incompetence	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Palpitations	1.9% 3/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Silent myocardial infarction	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Tachycardia	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Cardiac disorders Ventricular extrasystoles	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Congenital, familial and genetic disorders Peutz-Jeghers syndrome	0.64% 1/156 • Number of events 1 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Ear and labyrinth disorders Tinnitus	0.64% 1/156 • Number of events 1 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Endocrine disorders Basedow's disease	0.64% 1/156 • Number of events 2 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Endocrine disorders Goitre	0.64% 1/156 • Number of events 2 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Age-related macular degeneration	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Cataract	3.2% 5/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Diplopia	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Dry eye	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Entropion	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Epiretinal membrane	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Eye irritation	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Eye pain	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Macular degeneration	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Meibomian gland dysfunction	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Retinal haemorrhage	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Retinal tear	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Eye disorders Vitreous detachment	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Abdominal pain	0.64% 1/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Abdominal pain upper	0.64% 1/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Anal incontinence	0.64% 1/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Constipation	1.3% 2/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Diverticulum intestinal	0.64% 1/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Dry mouth	0.64% 1/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Dysphagia	0.64% 1/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Gastritis	1.3% 2/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.64% 1/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Haematemesis	0.64% 1/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Hiatus hernia	0.64% 1/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Inguinal hernia strangulated	0.64% 1/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Irritable bowel syndrome	0.64% 1/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Large intestine polyp	0.64% 1/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Nausea	1.3% 2/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Gastrointestinal disorders Rectal haemorrhage	1.3% 2/156 • Number of events 14 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Adverse drug reaction	0.64% 1/156 • Number of events 18 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Catheter site inflammation	0.64% 1/156 • Number of events 18 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Chest pain	3.2% 5/156 • Number of events 18 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Early satiety	0.64% 1/156 • Number of events 18 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Fatigue	0.64% 1/156 • Number of events 18 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Gait disturbance	0.64% 1/156 • Number of events 18 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Impaired healing	1.3% 2/156 • Number of events 18 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Non-cardiac chest pain	0.64% 1/156 • Number of events 18 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Pain	1.3% 2/156 • Number of events 18 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Peripheral swelling	1.9% 3/156 • Number of events 18 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
General disorders Pyrexia	1.3% 2/156 • Number of events 18 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Hepatobiliary disorders Hepatic lesion	0.64% 1/156 • Number of events 1 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations COVID-19	0.64% 1/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Cellulitis	0.64% 1/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Cystitis	0.64% 1/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Diverticulitis	1.3% 2/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Erysipelas	0.64% 1/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Influenza	1.3% 2/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Lower respiratory tract infection	1.9% 3/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Onychomycosis	0.64% 1/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Pneumonia	0.64% 1/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Post procedural infection	1.3% 2/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Post-acute COVID-19 syndrome	0.64% 1/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Respiratory syncytial virus infection	0.64% 1/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Urinary tract infection	0.64% 1/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Infections and infestations Viral infection	0.64% 1/156 • Number of events 16 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Arthropod bite	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Back injury	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Bone contusion	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Burns second degree	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Cartilage injury	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Chest injury	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Clavicle fracture	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Contusion	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Fall	1.9% 3/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Humerus fracture	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Jaw fracture	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Joint dislocation	1.3% 2/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Joint injury	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Meniscus injury	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Muscle strain	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Musculoskeletal foreign body	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Osteoradionecrosis	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Overdose	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Procedural nausea	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Procedural vomiting	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Rib fracture	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Scapula fracture	1.3% 2/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Soft tissue injury	1.3% 2/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Spinal compression fracture	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Sternal Fracture	0.64% 1/156 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Thermal burn	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Traumatic haematoma	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Ulna fracture	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Ulnar nerve injury	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Upper limb fracture	1.9% 3/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Wound	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Injury, poisoning and procedural complications Wrist fracture	1.3% 2/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Investigations Crystal urine present	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Investigations HLA marker study positive	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Investigations Staphylococcus test positive	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Investigations Weight decreased	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Metabolism and nutrition disorders Abnormal loss of weight	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Metabolism and nutrition disorders Decreased appetite	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Metabolism and nutrition disorders Gout	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Metabolism and nutrition disorders Hypercholesterolaemia	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Arthralgia	18.6% 29/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Arthritis	1.3% 2/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Arthropathy	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Bone infarction	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Back pain	3.8% 6/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Bursitis	1.9% 3/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Exostosis	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Finger deformity	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Foot deformity	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Fracture pain	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Greater trochanteric pain syndrome	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Joint instability	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Joint noise	1.3% 2/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	2.6% 4/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Joint swelling	1.9% 3/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Mobility decreased	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Muscle disorder	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Muscular weakness	1.3% 2/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	1.9% 3/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.1% 8/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	2.6% 4/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Neck pain	1.9% 3/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Osteoarthritis	16.0% 25/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Pain in extremity	4.5% 7/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Periarthritis	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	5.8% 9/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Soft tissue swelling	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	4.5% 7/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Tendon disorder	1.3% 2/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Tendon pain	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Musculoskeletal and connective tissue disorders Tendonitis	0.64% 1/156 • Number of events 69 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.6% 4/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.64% 1/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	1.3% 2/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.64% 1/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer	0.64% 1/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.64% 1/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.64% 1/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.64% 1/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Acquired syringomyelia	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Carpal tunnel syndrome	4.5% 7/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Dizziness	1.3% 2/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Headache	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Hypoaesthesia	1.9% 3/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Lumbar radiculopathy	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Memory impairment	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Migraine	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Neuralgia	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Neuropathy peripheral	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Paraesthesia	1.9% 3/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Pseudoradicular syndrome	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Sensory loss	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Spinal claudication	1.3% 2/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Nervous system disorders Transient ischaemic attack	0.64% 1/156 • Number of events 24 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Product Issues Device loosening	0.64% 1/156 • Number of events 1 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Psychiatric disorders Delirium	0.64% 1/156 • Number of events 3 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Psychiatric disorders Depression	0.64% 1/156 • Number of events 3 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Psychiatric disorders Panic attack	0.64% 1/156 • Number of events 3 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Renal and urinary disorders Chronic kidney disease	1.3% 2/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Renal and urinary disorders Haematuria	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Renal and urinary disorders Hydronephrosis	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Renal and urinary disorders Pollakiuria	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Renal and urinary disorders Urinary incontinence	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Renal and urinary disorders Urinary retention	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Renal and urinary disorders Urinary tract pain	0.64% 1/156 • Number of events 6 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Reproductive system and breast disorders Breast disorder	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Reproductive system and breast disorders Breast pain	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Reproductive system and breast disorders Breast swelling	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Reproductive system and breast disorders Vaginal prolapse	0.64% 1/156 • Number of events 4 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Respiratory, thoracic and mediastinal disorders Asthma	0.64% 1/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.64% 1/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Respiratory, thoracic and mediastinal disorders Cough	1.9% 3/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.6% 4/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	2.6% 4/156 • Number of events 12 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Skin and subcutaneous tissue disorders Actinic keratosis	1.3% 2/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Skin and subcutaneous tissue disorders Blister	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Skin and subcutaneous tissue disorders Dermatitis contact	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Skin and subcutaneous tissue disorders Rash	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Skin and subcutaneous tissue disorders Skin lesion	2.6% 4/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Skin and subcutaneous tissue disorders Skin ulcer	0.64% 1/156 • Number of events 11 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Vascular disorders Aortic aneurysm	0.64% 1/156 • Number of events 9 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Vascular disorders Haematoma	3.8% 6/156 • Number of events 9 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Vascular disorders Hypertension	0.64% 1/156 • Number of events 9 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Vascular disorders Peripheral coldness	0.64% 1/156 • Number of events 9 • Day 0 (Day of surgery) up to 60 months All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.

Additional Information

Dave Whalen

DePuy Synthes

Phone: 574-404-9399

Email: dwhalen@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60