Trial Outcomes & Findings for Tritanium® Primary Acetabular Shell Study (NCT NCT01063751)

Last Updated: 2025-04-16

Results Overview

To evaluate the success rate of cementless primary total hip replacement (THR) in hips implanted with the Tritanium® Acetabular Shell, as compared to the published results of similar acetabular components. Success will be defined as absence of acetabular shell revision for any reason at 5 years postoperative. It is expected that the survivorship of the Tritanium® Acetabular Shell group will be non-inferior to the survivorship reported in the literature for similar competitive devices.

Recruitment status

TERMINATED

Study phase

Target enrollment

275 participants

Primary outcome timeframe

5 years

Results posted on

2025-04-16

Participant Flow

275 participants/284 hip cases were enrolled. There were 266 unilateral hip cases and 9 bilateral hips cases.

Unit of analysis: Hips

Participant milestones

Participant milestones
Measure	Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.
Overall Study STARTED	275 284
Overall Study COMPLETED	41 43
Overall Study NOT COMPLETED	234 241

Reasons for withdrawal

Reasons for withdrawal
Measure	Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.
Overall Study Censored from analyses	42
Overall Study Withdrawal by Subject	34
Overall Study Lost to Follow-up	30
Overall Study Death	13
Overall Study Sponsored Terminated Study	60
Overall Study Cases terminated due to investigator leaving the site and site closure.	35
Overall Study Investigator site closed	10
Overall Study Revision	6
Overall Study Physician Decision	4

Baseline Characteristics

Tritanium® Primary Acetabular Shell Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tritanium® Primary Acetabular Shell n=241 hips Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.
Age, Continuous	62.60 years n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	134 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants
Race (NIH/OMB) White	207 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	241 Cases n=241 hips

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Tritanium® Primary Acetabular Shell n=241 hips Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.
Absence of Acetabular Revision	6 hips

SECONDARY outcome

Timeframe: Intraoperative

Population: Bone screws used.

Usage of bone screw fixation will be recorded and compared between the Tritanium® Acetabular Shell group and the Trident® Hemispherical Acetabular (HA) Shell group (Trident® X3® Polyethylene Insert Study).

Outcome measures

Outcome measures
Measure	Tritanium® Primary Acetabular Shell n=241 Hips Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.
Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell Yes	178 Hips
Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell No	63 Hips

SECONDARY outcome

Timeframe: 1, 3, and 5 years

Population: A calculable HHS score is a case where all data points are present to calculate the stated score.

The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor

Outcome measures

Outcome measures
Measure	Tritanium® Primary Acetabular Shell n=241 Hips Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.
Harris Hip Score 1-Year Harris Hip Score	90.01 Score on a scale Standard Deviation 13.6
Harris Hip Score 3-Year Harris Hip Score	90.99 Score on a scale Standard Deviation 13.64
Harris Hip Score 5-Year Harris Hip Score	90.7 Score on a scale Standard Deviation 14.37

SECONDARY outcome

Timeframe: 1, 3, and 5 years

Population: An evaluable case is one where all data points are present to calculate the stated score.

The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

Outcome measures

Outcome measures
Measure	Tritanium® Primary Acetabular Shell n=241 Hips Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.
Short Form- 12 (SF-12) Heath Survey Scores 1-Year Mental Component Score	55.26 Score on a scale Standard Deviation 8.95
Short Form- 12 (SF-12) Heath Survey Scores 3-Year Physical Component Score	46.62 Score on a scale Standard Deviation 10.48
Short Form- 12 (SF-12) Heath Survey Scores 3-Year Mental Component Score	55.63 Score on a scale Standard Deviation 8.51
Short Form- 12 (SF-12) Heath Survey Scores 5-Year Physical Component Score	46.68 Score on a scale Standard Deviation 10.38
Short Form- 12 (SF-12) Heath Survey Scores 1-Year Physical Component Score	46.77 Score on a scale Standard Deviation 10.45
Short Form- 12 (SF-12) Heath Survey Scores 5-Year Mental Component Score	55.34 Score on a scale Standard Deviation 7.78

SECONDARY outcome

Timeframe: 1, 3, and 5 years

Population: An evaluable case is one where all data points are present to calculate the stated score.

The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.

Outcome measures

Outcome measures
Measure	Tritanium® Primary Acetabular Shell n=241 Hips Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.
Lower Extremity Activity Scale (LEAS) Score 1-Year LEAS	10.74 Score on a scale Standard Deviation 3.06
Lower Extremity Activity Scale (LEAS) Score 3-Year LEAS	11.61 Score on a scale Standard Deviation 3.11
Lower Extremity Activity Scale (LEAS) Score 5-Year LEAS	11.11 Score on a scale Standard Deviation 3.41

SECONDARY outcome

Timeframe: 1,2,3,4, and 5 years

Population: A calculable case is one where all data points are present to calculate the stated score.

The EuroQol five-dimensional (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas: the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health. The index values on a scale between -1 (low) and 1 (high) are showing the average health status. A low score shows worse health, and a high score shows better health.

Outcome measures

Outcome measures
Measure	Tritanium® Primary Acetabular Shell n=241 Hips Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.
EuroQol Five-Dimensional (EQ-5D) 5-Year EQ5D TTO Valuation Over Time	.86 Score on a scale Standard Deviation .15
EuroQol Five-Dimensional (EQ-5D) 1-Year EQ5D Health State Over Time	79.87 Score on a scale Standard Deviation 17.32
EuroQol Five-Dimensional (EQ-5D) 1-Year EQ5D TTO Valuation Over Time	.87 Score on a scale Standard Deviation .16
EuroQol Five-Dimensional (EQ-5D) 2-Year EQ5D Health State Over Time	79.87 Score on a scale Standard Deviation 17.01
EuroQol Five-Dimensional (EQ-5D) 2-Year EQ5D TTO Valuation Over Time	.84 Score on a scale Standard Deviation .18
EuroQol Five-Dimensional (EQ-5D) 3-Year EQ5D Health State Over Time	82.75 Score on a scale Standard Deviation 13.62
EuroQol Five-Dimensional (EQ-5D) 3-Year EQ5D TTO Valuation Over Time	.88 Score on a scale Standard Deviation .15
EuroQol Five-Dimensional (EQ-5D) 4-Year EQ5D Health State Over Time	80.8 Score on a scale Standard Deviation 15.55
EuroQol Five-Dimensional (EQ-5D) 4-Year EQ5D TTO Valuation Over Time	.86 Score on a scale Standard Deviation .14
EuroQol Five-Dimensional (EQ-5D) 5-Year EQ5D Health State Over Time	80.95 Score on a scale Standard Deviation 16.78

SECONDARY outcome

Timeframe: 6, 7, 8, 9, and 10 years

Population: Not all participants completed the Follow-Up Questionnaire at the respective timepoints.

The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, pain, and whether or not there have been any revisions or removals since the last follow-up visit. It consists of three questions: * Patient satisfaction with the hip replacement * Presence of any pain in the study hip * Any surgeries performed on the study hip

Outcome measures

Outcome measures
Measure	Tritanium® Primary Acetabular Shell n=241 Hips Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.
Follow-Up Questionnaire 6-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES	25 Hips
Follow-Up Questionnaire 7-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO	3 Hips
Follow-Up Questionnaire 10-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES	6 Hips
Follow-Up Questionnaire 6-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO	74 Hips
Follow-Up Questionnaire 6-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES	96 Hips
Follow-Up Questionnaire 6-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO	3 Hips
Follow-Up Questionnaire 6-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES	1 Hips
Follow-Up Questionnaire 6-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO	98 Hips
Follow-Up Questionnaire 7-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES	25 Hips
Follow-Up Questionnaire 7-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO	64 Hips
Follow-Up Questionnaire 7-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES	86 Hips
Follow-Up Questionnaire 7-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES	0 Hips
Follow-Up Questionnaire 7-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO	89 Hips
Follow-Up Questionnaire 8-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES	14 Hips
Follow-Up Questionnaire 8-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO	50 Hips
Follow-Up Questionnaire 8-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES	61 Hips
Follow-Up Questionnaire 8-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO	3 Hips
Follow-Up Questionnaire 8-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES	0 Hips
Follow-Up Questionnaire 8-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO	64 Hips
Follow-Up Questionnaire 9-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES	8 Hips
Follow-Up Questionnaire 9-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO	31 Hips
Follow-Up Questionnaire 9-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES	38 Hips
Follow-Up Questionnaire 9-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO	1 Hips
Follow-Up Questionnaire 9-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES	0 Hips
Follow-Up Questionnaire 9-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO	39 Hips
Follow-Up Questionnaire 10-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO	37 Hips
Follow-Up Questionnaire 10-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES	41 Hips
Follow-Up Questionnaire 10-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO	2 Hips
Follow-Up Questionnaire 10-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES	0 Hips
Follow-Up Questionnaire 10-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO	43 Hips

SECONDARY outcome

Timeframe: 6 weeks, 1, 3, 5 years

Population: Frequency of the acetabular shell stability.

Numerous parameters will be reviewed by zone, including radiolucency and migration. All data will be evaluated in order to classify each case as stable or unstable.

Outcome measures

Outcome measures
Measure	Tritanium® Primary Acetabular Shell n=241 Hips Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.
Acetabular Shell Radiographic Stability 6- Weeks Postoperative: Stable	227 Hips
Acetabular Shell Radiographic Stability 6- Weeks Postoperative: Fibrous Stable	0 Hips
Acetabular Shell Radiographic Stability 6- Weeks Postoperative: Unstable	0 Hips
Acetabular Shell Radiographic Stability 1-Year Postoperative: Stable	192 Hips
Acetabular Shell Radiographic Stability 1-Year Postoperative: Fibrous Stable	2 Hips
Acetabular Shell Radiographic Stability 1-Year Postoperative: Unstable	0 Hips
Acetabular Shell Radiographic Stability 3-Years Postoperative: Stable	130 Hips
Acetabular Shell Radiographic Stability 3-Years Postoperative: Fibrous Stable	4 Hips
Acetabular Shell Radiographic Stability 3-Years Postoperative: Unstable	0 Hips
Acetabular Shell Radiographic Stability 5-Years Postoperative: Stable	85 Hips
Acetabular Shell Radiographic Stability 5-Years Postoperative: Fibrous Stable	3 Hips
Acetabular Shell Radiographic Stability 5-Years Postoperative: Unstable	3 Hips

Adverse Events

Operative Site Adverse Event(s)

Serious events: 16 serious events

Other events: 61 other events

Deaths: 0 deaths

Non-operative Site Adverse Event(s)

Serious events: 56 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Operative Site Adverse Event(s) n=241 participants at risk Operative site adverse events are reported by study hip because in the case of bilateral participants (participants who have the study device implanted in both hips), an event can occur in one hip, both hips or the same hip, but at different times and are counted as separate events for this reason.	Non-operative Site Adverse Event(s) n=234 participants at risk Non-operative site adverse events that were reported by participant.
Musculoskeletal and connective tissue disorders Operative Site	25.3% 61/241 • Number of events 90 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	0.00% 0/234 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.

Additional Information

Filesha Haniff / Clinical Study Manager

Stryker - Joint Replacement

Phone: 1 470.528.9214

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There is an agreement between Principal Investigators and the Sponsor (or its agents) that requires Investigators to allow Sponsor at least 30 days to review material intended for publications in order to redact any Confidential Information or Inventions therefrom.
Publication restrictions are in place

Restriction type: OTHER

Measure	Operative Site Adverse Event(s) n=241 participants at risk Operative site adverse events are reported by study hip because in the case of bilateral participants (participants who have the study device implanted in both hips), an event can occur in one hip, both hips or the same hip, but at different times and are counted as separate events for this reason.	Non-operative Site Adverse Event(s) n=234 participants at risk Non-operative site adverse events that were reported by participant.
Infections and infestations Operative Site	2.5% 6/241 • Number of events 6 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	0.00% 0/234 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Injury, poisoning and procedural complications Operative Site	0.83% 2/241 • Number of events 2 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	0.00% 0/234 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Musculoskeletal and connective tissue disorders Operative Site	2.9% 7/241 • Number of events 9 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	0.00% 0/234 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Blood and lymphatic system disorders Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	0.85% 2/234 • Number of events 3 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Cardiac disorders Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	7.3% 17/234 • Number of events 19 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Eye disorders Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	0.43% 1/234 • Number of events 1 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Gastrointestinal disorders Non-operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	2.1% 5/234 • Number of events 7 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
General disorders Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	1.7% 4/234 • Number of events 4 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Hepatobiliary disorders Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	0.43% 1/234 • Number of events 1 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Infections and infestations Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	0.85% 2/234 • Number of events 2 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Musculoskeletal and connective tissue disorders Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	5.1% 12/234 • Number of events 13 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	6.0% 14/234 • Number of events 17 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Nervous system disorders Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	3.0% 7/234 • Number of events 10 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Psychiatric disorders Non-operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	0.43% 1/234 • Number of events 1 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Respiratory, thoracic and mediastinal disorders Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	1.7% 4/234 • Number of events 8 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Surgical and medical procedures Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	0.43% 1/234 • Number of events 1 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Vascular disorders Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	3.4% 8/234 • Number of events 8 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Renal and urinary disorders Non-Operative	0.00% 0/241 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	0.43% 1/234 • Number of events 1 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Operative	0.41% 1/241 • Number of events 1 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.	0.00% 0/234 • Participants were assessed up to 10 years. Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.