Trial Outcomes & Findings for A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing (NCT NCT02405208)

Last Updated: 2025-12-24

Results Overview

Clinical success was determined by the percentage of shoulders with device survival. Survival of the device was measured by the Kaplan-Meier survival estimate with survival defined as all the following: * Device remained implanted * Absence of device-related complications requiring surgical replacement, removal, or augmentation of components * Freedom from chronic dislocation

Recruitment status

COMPLETED

Target enrollment

156 participants

Primary outcome timeframe

up to 117 months

Results posted on

2025-12-24

Participant Flow

Overall, 156 participants were enrolled to the study at five (5) sites.

The Full Analysis Set (FAS) population includes 10 participants that received the TITAN device and 146 participants that received the PyroTITAN device. The TITAN device was renamed PyroTITAN by the previous sponsor (i.e., the same device). All participants were enrolled the same based on the eligibility criteria, so all participants are combined under the same primary cohort.

Participant milestones

Participant milestones
Measure	Primary Cohort Primary cohort will receive the PyroTITAN HRA device\* PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device.
Overall Study STARTED	156
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	83

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Cohort n=156 Participants Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device
Age, Continuous	59.5 years STANDARD_DEVIATION 11.0 • n=156 Participants
Sex: Female, Male Female	54 Participants n=156 Participants
Sex: Female, Male Male	102 Participants n=156 Participants
Body Mass Index (BMI)	29.00 kg/m^2 STANDARD_DEVIATION 4.8 • n=153 Participants • Number of participants analyzed indicated participants with data collected for the baseline measure specified.

PRIMARY outcome

Timeframe: up to 117 months

Population: Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants.

Outcome measures

Outcome measures
Measure	Primary cohort n=72 shoulders Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device
Device Survival	85.97 percentage of shoulders Interval 79.76 to 92.19

SECONDARY outcome

Timeframe: 2 years, 3 years, 4 years, 5 years, 8 years and 10 years

Population: Radiographic outcome data were not collected during the study period by the original sponsor, despite being specified in the protocol. As a result, this outcome measure could not be analyzed or reported. This limitation does not affect the reporting of other pre-specified primary and secondary outcomes, which have been summarized and submitted as per protocol.

Radiographic success determined by: * No evidence of device failure, specifically progressive migration or implant loosening * Anatomic alignment is a criterion that may be included in the definition of success in some investigations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

The ASES Shoulder Score is a functional outcome tool that has been validated for various shoulder conditions. ASES score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition.

Outcome measures

Outcome measures
Measure	Primary cohort n=153 Participants Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device
ASES Score 5 years	86.5 score on a scale Standard Deviation 17.2
ASES Score 8 years	87.5 score on a scale Standard Deviation 20.2
ASES Score 10 years	89.3 score on a scale Standard Deviation 12.6
ASES Score 4 years	87.4 score on a scale Standard Deviation 15.8
ASES Score Baseline	36.2 score on a scale Standard Deviation 16.1
ASES Score 3 months	66.0 score on a scale Standard Deviation 18.3
ASES Score 6 months	78.3 score on a scale Standard Deviation 18.4
ASES Score 1 year	82.5 score on a scale Standard Deviation 17.8
ASES Score 2 years	86.0 score on a scale Standard Deviation 17.6
ASES Score 3 years	85.7 score on a scale Standard Deviation 17.4

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

The Visual Analog Scale (VAS) Pain Score ranges from 0 to 100, with 0 representing no pain (i.e., the best outcome) and 100 representing the worst possible pain (i.e., the worst outcome).

Outcome measures

Outcome measures
Measure	Primary cohort n=154 Participants Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device
Visual Analog Scale (VAS) Pain Score Baseline	64.1 score on a scale Standard Deviation 20.3
Visual Analog Scale (VAS) Pain Score 3 months	24.2 score on a scale Standard Deviation 21.1
Visual Analog Scale (VAS) Pain Score 6 months	18.1 score on a scale Standard Deviation 20.2
Visual Analog Scale (VAS) Pain Score 1 year	15.5 score on a scale Standard Deviation 19.5
Visual Analog Scale (VAS) Pain Score 2 years	13.2 score on a scale Standard Deviation 19.4
Visual Analog Scale (VAS) Pain Score 3 years	15.5 score on a scale Standard Deviation 21.2
Visual Analog Scale (VAS) Pain Score 4 years	12.1 score on a scale Standard Deviation 18.1
Visual Analog Scale (VAS) Pain Score 8 years	12.7 score on a scale Standard Deviation 21.9
Visual Analog Scale (VAS) Pain Score 10 years	9.2 score on a scale Standard Deviation 12.0
Visual Analog Scale (VAS) Pain Score 5 years	13.4 score on a scale Standard Deviation 19.6

SECONDARY outcome

Timeframe: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

Patient satisfaction determined by the Visual Analog Scale (VAS) Satisfaction score. VAS Satisfaction scores range from 0 to 100, with 0 representing the lowest level of satisfaction (i.e., the worst possible outcome) and 100 representing the highest level of satisfaction (i.e., the best possible outcome).

Outcome measures

Outcome measures
Measure	Primary cohort n=151 Participants Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device
Visual Analog Scale (VAS) Satisfaction Score 3 months	75.8 score on a scale Standard Deviation 25.1
Visual Analog Scale (VAS) Satisfaction Score 6 months	81.1 score on a scale Standard Deviation 23.3
Visual Analog Scale (VAS) Satisfaction Score 1 year	84.0 score on a scale Standard Deviation 21.8
Visual Analog Scale (VAS) Satisfaction Score 2 years	85.6 score on a scale Standard Deviation 21.8
Visual Analog Scale (VAS) Satisfaction Score 3 years	85.6 score on a scale Standard Deviation 19.6
Visual Analog Scale (VAS) Satisfaction Score 4 years	86.3 score on a scale Standard Deviation 18.5
Visual Analog Scale (VAS) Satisfaction Score 5 years	86.1 score on a scale Standard Deviation 21.3
Visual Analog Scale (VAS) Satisfaction Score 8 years	86.2 score on a scale Standard Deviation 24.2
Visual Analog Scale (VAS) Satisfaction Score 10 years	88.6 score on a scale Standard Deviation 18.0

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

The WOOS Score is a quality of life questionnaire that has been validated for various shoulder conditions. WOOS total score ranges from 0 to 100, with 0 representing the best shoulder condition and 100 representing the worst shoulder condition.

Outcome measures

Outcome measures
Measure	Primary cohort n=154 Participants Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device
The Western Ontario of the Shoulder Index (WOOS) Score 6 months	22.2 score on a scale Standard Deviation 19.2
The Western Ontario of the Shoulder Index (WOOS) Score 1 year	18.6 score on a scale Standard Deviation 19.5
The Western Ontario of the Shoulder Index (WOOS) Score 4 years	14.2 score on a scale Standard Deviation 16.8
The Western Ontario of the Shoulder Index (WOOS) Score 5 years	13.8 score on a scale Standard Deviation 15.6
The Western Ontario of the Shoulder Index (WOOS) Score 8 years	12.6 score on a scale Standard Deviation 19.9
The Western Ontario of the Shoulder Index (WOOS) Score 10 years	11.8 score on a scale Standard Deviation 13.9
The Western Ontario of the Shoulder Index (WOOS) Score Baseline	65.1 score on a scale Standard Deviation 15.0
The Western Ontario of the Shoulder Index (WOOS) Score 3 months	34.3 score on a scale Standard Deviation 19.9
The Western Ontario of the Shoulder Index (WOOS) Score 2 years	15.3 score on a scale Standard Deviation 19.3
The Western Ontario of the Shoulder Index (WOOS) Score 3 years	15.2 score on a scale Standard Deviation 17.0

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

The Constant-Murley (CM) Score is a commonly used score of shoulder function. CM scores range from 0 to 100, with a score of 0 indicating a worse shoulder function (i.e., worst outcome) and 100 indicating the best shoulder function (i.e., best outcome).

Outcome measures

Outcome measures
Measure	Primary cohort n=132 Participants Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device
Constant-Murley (CM) Score Baseline	39.4 score on a scale Standard Deviation 17.6
Constant-Murley (CM) Score 2 years	82.5 score on a scale Standard Deviation 13.4
Constant-Murley (CM) Score 3 years	81.5 score on a scale Standard Deviation 14.1
Constant-Murley (CM) Score 4 years	82.1 score on a scale Standard Deviation 12.1
Constant-Murley (CM) Score 5 years	82.8 score on a scale Standard Deviation 12.3
Constant-Murley (CM) Score 8 years	83.4 score on a scale Standard Deviation 12.4
Constant-Murley (CM) Score 10 years	80.9 score on a scale Standard Deviation 11.6
Constant-Murley (CM) Score 3 months	57.3 score on a scale Standard Deviation 18.8
Constant-Murley (CM) Score 6 months	72.5 score on a scale Standard Deviation 17.7
Constant-Murley (CM) Score 1 year	78.8 score on a scale Standard Deviation 16.0

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

The EuroQol 5-Dimension 3-Level (EQ-5D-3L) Quality of Life Score ranges on a scale of 0 to 1, with 0 indicating a worse health condition (i.e., worst outcome) and 1 indicating the best health condition (i.e., best outcome).

Outcome measures

Outcome measures
Measure	Primary cohort n=154 Participants Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device
EQ-5D-3L Quality of Life Score 4 years	0.887 score on a scale Standard Deviation 0.105
EQ-5D-3L Quality of Life Score 5 years	0.886 score on a scale Standard Deviation 0.114
EQ-5D-3L Quality of Life Score 8 years	0.888 score on a scale Standard Deviation 0.132
EQ-5D-3L Quality of Life Score 10 years	0.877 score on a scale Standard Deviation 0.121
EQ-5D-3L Quality of Life Score Baseline	0.759 score on a scale Standard Deviation 0.087
EQ-5D-3L Quality of Life Score 3 months	0.824 score on a scale Standard Deviation 0.097
EQ-5D-3L Quality of Life Score 6 months	0.860 score on a scale Standard Deviation 0.098
EQ-5D-3L Quality of Life Score 1 year	0.886 score on a scale Standard Deviation 0.098
EQ-5D-3L Quality of Life Score 2 years	0.870 score on a scale Standard Deviation 0.101
EQ-5D-3L Quality of Life Score 3 years	0.883 score on a scale Standard Deviation 0.100

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

The EuroQol 5-Dimension 3-Level (EQ-5D-3L) Visual Analog Scale (VAS) Score ranges on a scale of 0 to 100, with 0 indicating a worse health condition (i.e., worst outcome) and 100 indicating the best health condition (i.e., best outcome).

Outcome measures

Outcome measures
Measure	Primary cohort n=154 Participants Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device
EQ-5D-3L VAS Score Baseline	61.9 score on a scale Standard Deviation 23.7
EQ-5D-3L VAS Score 3 months	69.0 score on a scale Standard Deviation 19.0
EQ-5D-3L VAS Score 10 years	73.2 score on a scale Standard Deviation 18.8
EQ-5D-3L VAS Score 6 months	71.3 score on a scale Standard Deviation 21.7
EQ-5D-3L VAS Score 1 year	75.7 score on a scale Standard Deviation 17.6
EQ-5D-3L VAS Score 2 years	75.2 score on a scale Standard Deviation 16.4
EQ-5D-3L VAS Score 3 years	70.6 score on a scale Standard Deviation 22.0
EQ-5D-3L VAS Score 4 years	71.9 score on a scale Standard Deviation 19.4
EQ-5D-3L VAS Score 5 years	72.7 score on a scale Standard Deviation 22.3
EQ-5D-3L VAS Score 8 years	76.8 score on a scale Standard Deviation 17.9

Adverse Events

Primary Cohort

Serious events: 51 serious events

Other events: 36 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Primary Cohort n=156 participants at risk Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device
Surgical and medical procedures ABDOMINAL HERNIA	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
General disorders AGGRAVATION OF HERNIATED DISC	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Cardiac disorders ANGINA ON EXERTION	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Cardiac disorders ARRHYTHMIA	1.3% 2/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders ARTHRITIS IN LEFT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders ARTHRITIS IN RT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Cardiac disorders ATRIAL FIBRILLATION	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN TUMOUR IN RIGHT KNEE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders BILATERAL ROTATOR CUFF DEGENERATION	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders BROKEN LEFT WRIST	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Cardiac disorders CARDIAC ARREST	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Cardiac disorders CARDIAC ARRHYTHMIA	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Cardiac disorders CHEST PAIN ON EXERTION	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Product Issues CRACK IN PROSTHESIS	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
General disorders CUT ON LEFT INDEX FINGER USING DROP SAW	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Product Issues DEVICE BREAKAGE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Gastrointestinal disorders DIVERTICULITIS	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Product Issues FRACTURE IN HEAD OF IMPLANT	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Product Issues FRACTURE OF PYROTITAN IMPLANT	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Product Issues FRACTURED IMPLANT/PYROTITAN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Renal and urinary disorders GALL STONES	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Product Issues IMPLANT BREAKAGE	1.3% 2/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Product Issues IMPLANT BREAKAGE RIGHT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Product Issues IMPLANT FRACTURE DUE TO A FALL	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders INCREASING LEFT SHOULDER PAIN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Infections and infestations INFLUENZA A	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Infections and infestations INFLUENZA TYPE A	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Renal and urinary disorders KIDNEY STONES	1.3% 2/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders LEFT ELBOW PAIN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MELANOMA	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MELANOMA (CLARKS LEVEL 4)	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MELANOMA (LEFT BIG TOE)	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Nervous system disorders MULTIPLE SCLEROSIS	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Infections and infestations NECTROTISING INFLAMMATION OF RIGHT LUNG	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders NERVE PAIN IN LOWER BACK EXACERBATED	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders ONGOING LEFT SHOULDER PAIN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders PERSISTENT PAIN IN RIGHT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	1.3% 2/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Renal and urinary disorders PROSTATE INFECTION	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Nervous system disorders RADIAL NERVE PALSY	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
General disorders REACTION TO IV DYE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Gastrointestinal disorders REFLUX	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Product Issues REVERSE TOTAL PROSTESIS LEFT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders RIGHT ELBOW PAIN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders RIGHT HAND CARPAL TUNNEL SYNDROME	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders RIGHT HIP BURSITIS	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Cardiac disorders RIGHT KNEE PAIN / MENISCUS TEAR	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders RIGHT ROTATOR CUFF INJURY	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders RIGHT ROTATOR CUFF TENDONITIS	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders RIGHT SHOULDER TENDINOPATHY	1.3% 2/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders RUPTURED SPINAL DISCS	1.3% 2/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders SPINAL STENOSIS	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Renal and urinary disorders STAGE 3 CHRONIC KIDNEY DISEASE.	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Infections and infestations STAPH INFECTION IN RIGHT FOREARM	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Renal and urinary disorders STONE IN GALL BLADDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Vascular disorders STROKE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Nervous system disorders STROKE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Nervous system disorders STROKE ATTACK	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID CANCER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Vascular disorders TIA	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Eye disorders TORN RETINA IN RIGHT EYE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders TRAUMA TO THE LEFT KNEE.	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING (R) SHOULDER PAIN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING ARTHRITIS IN RIGHT KNEE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING ARTHRITIS PAIN LEFT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING KNEE PAIN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING KNEE PAIN (CATCHING)	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OA IN LEFT AND RIGHT KNEE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OA IN LEFT AND RIGHT KNEE due to BILATERAL TOTAL KNEE REPLACEMENT	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OA IN LEFT KNEE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OA RIGHT KNEE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF BILATERAL KNEE OA	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF LEFT KNEE OA.	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF LEFT KNEE OSTEOARTHRITIS	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF LEFT SHOULDER OA	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF OA IN LEFT SHOULDER	1.3% 2/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF OA IN RIGHT KNEE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF OA IN RIGHT SHOULDER	1.3% 2/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF OA IN RIGHT THUMB	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF PRE-EXISTING BACK PAIN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
General disorders WORSENING OF PRE-EXISTING HERNIA	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF RIGHT KNEE PAIN/ARTHRITIS	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF RIGHT SHOULDER OA.	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF RIGHT SHOULDER PAIN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OSTEOARTHRITIS IN LEFT KNEE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING PAIN IN RIGHT KNEE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING R) HIP OA	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.

Other adverse events

Other adverse events
Measure	Primary Cohort n=156 participants at risk Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device
Musculoskeletal and connective tissue disorders PERSISTENT RIGHT SHOULDER PAIN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders LEFT SHOULDER PAIN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders SEVERE INCREASE IN LEFT SHOULDER PAIN.	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders LEFT ROTATOR CUFF TENDONITIS	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders MARGINAL OSTEOPHYTE R GLENOID	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders CYSTIC CHANGES IN GLENOID NOTED ON MRI	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
General disorders TRANSIENT SQUEAK	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
General disorders HAD TREE FALL ON BACK AND SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders LUCENT FRACTURE	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders WORSENING OF RIGHT MCP AND CMCJ OSTEOARTHRITIS	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders "SQUEAKING" SOUND FROM JOINT OF RIGHT SHOULDER WITH MOVEMENT	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders PINS-AND-NEEDLES IN R THUMB/INDEX/MIDDLE FINGER, RADIATING TO ELBOW AND INTO R BREAST	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
General disorders VAGAL EPISODE (DIZZY / FAINTING) POST SURGERY SECONDARY TO PAIN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders TENDONITIS OF LEFT SHOULDER- CLICKING/PAINFUL SENSATION WITH SHOULDER MOVEMENT	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders PAIN AND WEAKNESS IN RIGHT SHOULDER WHEN OVERWORKED.	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders ROTATOR CUFF TENDINOPATHY OF RIGHT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders SQUEAKING SOUND IN LEFT SHOULDER / PYROTITAN WITH MOVEMENT OF SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders PERSISTENT PAIN IN ANTERIOR LEFT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders OCCASIONAL SQUEAK FROM IMPLANT. NOT PAINFUL	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders ROTATOR CUFF DYSFUNCTION IN RIGHT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders LEFT SIDED FORAMINA STENOSIS AT C5 AND C6	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders INCREASED GRINDING/CLICKING IN LEFT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Nervous system disorders NERVE DISTURBANCE IN DISTRIBUTION OF MUSCULOCUTANEOUS NERVE AND/OR C6/C7	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders SQUEAK IN RIGHT SHOULDER JOINT WITH MOVEMENT	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders MINIMAL INFERIOR OSTEOPHYTE GLENOID. - XR + MRI REPORT.	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders ASYMPTOMATIC MARKED SUBARTICULAR CYSTIC CHANGES INVOLVING MID AND SUPERIOR GLENOID	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders SQUEAKING NOTED BY PATIENT FROM LEFT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders SUBCORTICAL CYST IN POSTERIOR GLENOID INCREASED IN MEASUREMENT (UP TO 11MM)	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders DIFFICULTY IMPLANTING (DIFFICULTY BROACHING, REAMING AND INSERTING)	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders OCCASSIONAL SQUEAK NOTED IN OPERATIVE SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders FELL ONTO A OUTSTRETCHED ARM. NOW PAINFUL, TIGHT IN DELTOID REGION	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
General disorders PROSTHETIC LOOSENING	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders FALL OFF BACK OF CAMPING BUS 1.5 METRES	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Nervous system disorders RADIAL NERVE PALSY	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders ANTERIOR DELTOID ATROPHY MODERATE STIFFNESS	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Nervous system disorders NERVE PAIN AND MILD LOSS OF SENSIBILITY IN DIGITS 1 AND 2 LEFT HAND	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders SUFFERED A FISSURE FRACTURE COLLUM CHIRURGICUM LEFT SIDE.	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Nervous system disorders AXILLARY NERVE DAMAGE RIGHT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders CUFF TENDINITIS IN RIGHT SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders ONGOING PAIN IN LEFT SHOULDER	1.3% 2/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders INCREASED PAIN IN OPERATIVE SHOULDER	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Musculoskeletal and connective tissue disorders LEFT SHOULDER NERVE IMPINGEMEN	0.64% 1/156 • Adverse events were collected upon implantation of the study device to the end of study, up to 10 years. Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.

Additional Information

Senior Manager Clinical Compliance

Smith+Nephew, Inc

Phone: +44 7811 407089

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period up to 60 days but less than or equal to 120 days from the time submitted to the sponsor for review. Sponsor may delay publication up to 120 days to permit the filing of appropriate patent applications if the sponsor believes any publication contains any information relating to patentable items and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER