Trial Outcomes & Findings for Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe (NCT NCT03566082)

NCT ID: NCT03566082

Last Updated: 2024-05-30

Results Overview

Number of participants hip implant survivorship with implant survival defined as no revision through 10 years (i.e., 'Hip Survived' or 'Hip Did Not Survive').

• Recruitment status: COMPLETED
• Target enrollment: 135 participants
• Primary outcome timeframe: 10 Years
• Results posted on: 2024-05-30

Participant Flow

Participants previously recruited & enrolled in the post-market approval (PMA) were considered enrolled in this post-approval study (PAS). Additional consent was not required (reviewed and approved by study sites' ethic committees) because the participants had existing consent from the PMA agreeing to be followed to the 10-year postoperative interval necessary for this PAS.

Participant milestones

Measure	Post Approval Study Participants implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study.
Overall Study STARTED	135
Overall Study COMPLETED	118
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Post Approval Study Participants implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study.
Overall Study Death	7
Overall Study Failures (revision required)	2
Overall Study Lost to Follow-up	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Post Approval Study n=135 Participants Participants implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study.
Age, Continuous	61.2 years STANDARD_DEVIATION 9.12 • n=135 Participants
Sex: Female, Male Female	89 Participants n=135 Participants
Sex: Female, Male Male	46 Participants n=135 Participants
Region of Enrollment Belgium	61 Participants n=135 Participants
Region of Enrollment Finland	32 Participants n=135 Participants
Region of Enrollment United Kingdom	22 Participants n=135 Participants
Region of Enrollment Spain	20 Participants n=135 Participants
Body Mass Index (BMI)	27.7 kg/m^2 STANDARD_DEVIATION 4.73 • n=135 Participants

PRIMARY outcome

Timeframe: 10 Years

Population: Participants with any data available at the time frame specified

Number of participants hip implant survivorship with implant survival defined as no revision through 10 years (i.e., 'Hip Survived' or 'Hip Did Not Survive').

Outcome measures

Measure	Post Approval Study n=135 Participants Participants implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study.
Implant Survivorship Hip Survived	133 Participants
Implant Survivorship Hip Did Not Survive (Revision Required)	2 Participants

SECONDARY outcome

Timeframe: Pre-operative, 3-years, 5-years, 7-years, 10-years

Population: Participants with data available at time frames specifies

The mHHS scoring assessment ranges from 0 (worst) to 100 (best). Scores assessed during the pre-operative, 3-year, 5-year, 7-year and 10-year visit.

Outcome measures

Measure	Post Approval Study n=128 Participants Participants implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study.
Modified Harris Hip Score (mHHS) 7-year	92 score on a scale Standard Deviation 10.83
Modified Harris Hip Score (mHHS) Pre-operative	47.9 score on a scale Standard Deviation 12.02
Modified Harris Hip Score (mHHS) 3-year	92 score on a scale Standard Deviation 11.42
Modified Harris Hip Score (mHHS) 5-year	92.5 score on a scale Standard Deviation 10.61
Modified Harris Hip Score (mHHS) 10-year	92.6 score on a scale Standard Deviation 9.29

SECONDARY outcome

Timeframe: 3-years, 5-years, 7-years 10-years

Population: Number of participants with any data available for the time frame specified

Count of participants with radiographic success, where success is defined as:

• No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones; and
• No femoral or acetabular subsidence greater than or equal to 5mm from baseline; and
• No acetabular cup inclination changes greater than 4 degrees (4°)

Participants who did not meet criteria specified above were considered radiographic failures

Outcome measures

Measure	Post Approval Study n=115 Participants Participants implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study.
Number of Participants With Radiographic Success 3-years · Success	111 Participants
Number of Participants With Radiographic Success 3-years · Failures	4 Participants
Number of Participants With Radiographic Success 5-years · Success	101 Participants
Number of Participants With Radiographic Success 5-years · Failures	5 Participants
Number of Participants With Radiographic Success 7-years · Success	90 Participants
Number of Participants With Radiographic Success 7-years · Failures	5 Participants
Number of Participants With Radiographic Success 10-years · Success	97 Participants
Number of Participants With Radiographic Success 10-years · Failures	5 Participants

Adverse Events

Post Approval Study

Serious events: 83 serious events

Other events: 99 other events

Deaths: 7 deaths

Serious adverse events

Measure	Post Approval Study n=135 participants at risk Participants implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study.
Product Issues Aseptic implant (acetabular cup) loosening right hip	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix cancer	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Goiter adenoma	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	2.2% 3/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cel carcinoma	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelium cancer	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchus/lung cancer	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal/colon cancer	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Cardiac disorders Artery sclerosis	3.7% 5/135 • Number of events 5 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Cardiac disorders Cardiac arrhytmia	5.9% 8/135 • Number of events 8 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Cardiac disorders Cerebrovascular infarction	3.0% 4/135 • Number of events 4 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Cardiac disorders Deep vein trombosis	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Cardiac disorders Congestive heart failure descompensation	2.2% 3/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Cardiac disorders Hypertension	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Cardiac disorders Insufficienty mitral valve	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Cardiac disorders Takotsubo cardiomyopathy	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Cardiac disorders TIA	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Cardiac disorders Stroke	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Death	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Abcess	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Appendicitis	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Cholecystitis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Diarrhea	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Diverticulosis	2.2% 3/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Fistel	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Gastro-intestinal bleeding	0.74% 1/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Hernia Inguinalis	2.2% 3/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Rectosigmoidoal polyp	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Stomach perforation	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Abdominal pain due to dehydration	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Diabetes	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Acute liver failure	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Multinodular goiter	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Liver cirrosis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Pancreatitis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Eye disorders Blepharochalasis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Eye disorders Cataract	7.4% 10/135 • Number of events 15 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Eye disorders Degeneration	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Eye disorders Subluxation eye lens	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Immune system disorders Hypokaliemia	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Infections and infestations Surgical wound infection	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Infections and infestations Sepsis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Injury, poisoning and procedural complications Induced coma due to road traffic accident	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Injury, poisoning and procedural complications Pelvic fracture due to a fall	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Injury, poisoning and procedural complications Wound head due to a fall	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Injury, poisoning and procedural complications Wound in face	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Leg pain	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Psychiatric disorders Alzheimer	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Psychiatric disorders Depression	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Psychiatric disorders Stress (extreme)	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Swelling	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Achilles tendon rupture	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Meniscus tear	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Muscle tear	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Tendon rupture	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Nervous system disorders Disc prolapse	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Nervous system disorders Carpal tunnel syndrome right	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Nervous system disorders Commotio cerebri	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Nervous system disorders Leuco-encefalopathy	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Nervous system disorders Corticosubcorticale atrophy	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Nervous system disorders Polyneuropathy	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Pain left hip due to a fall	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Worsening of the polyethylene liner wear + hip left side	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Reproductive system and breast disorders Hysterocele	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Reproductive system and breast disorders Benigne prostate hypertrophy	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Reproductive system and breast disorders Epidydimitis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Asthma	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Pneumonia	4.4% 6/135 • Number of events 6 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders COPD	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Emphysema	2.2% 3/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Lung oedema	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Pleura fluid	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Lung embolism	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Respiratory sepsis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Respiratory insuficience	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Acetabular component loosening	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Arthrosis	3.7% 5/135 • Number of events 6 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders broken tooth	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Fracture	5.9% 8/135 • Number of events 9 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Contusio	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Foot Surgery	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Hernia	3.7% 5/135 • Number of events 5 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Impingement	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Labral tear	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Pain	3.0% 4/135 • Number of events 4 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Spinal stenosis	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Trigger finger	0.74% 1/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Revision surgery	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Wound	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Folliculitis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Ingrown toenail	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Laceration	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Correction abdominal wall	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Headache, right eye visual symptoms for unknown reason	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Hiccup	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Renal and urinary disorders Acute Kidney failure	3.0% 4/135 • Number of events 4 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Renal and urinary disorders Hydro-uretronetrosis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Renal and urinary disorders Hematurie	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Renal and urinary disorders Chronic Kidney failure	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Renal and urinary disorders Hydrometrose	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Renal and urinary disorders Renal insufficiency	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Renal and urinary disorders Subnephrotic proteinaria due to her nephropathy	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.

Other adverse events

Measure	Post Approval Study n=135 participants at risk Participants implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study.
Vascular disorders Hypertension	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders Claudication	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders Diverticulitis aorta	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders Chronic venous insufficiency	2.2% 3/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders Syncope	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders Aneurysma	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders AV-block Grade I	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders Artery sclerosis	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders Cardiac arrhytmia	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders Deep vein trombosis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders Sinnus of arterial insufficiency	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders Peripheral arterial disease	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders Headache	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Vascular disorders Multiple brain ischemia chronic	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Abdominal pain	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Hemorrhagia Ex Ano	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Fecal incontinence	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Diverticulitis	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Nausea	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Hemorrhoids	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Anal swelling	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Pyrosis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Gastroesophageal reflux disease	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Gastrointestinal disorders Gastric pain	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Ear and labyrinth disorders Tinnitus	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Ear and labyrinth disorders Otitis externa	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Ear and labyrinth disorders Hearing impairment	3.0% 4/135 • Number of events 4 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Ear and labyrinth disorders Vertigo	2.2% 3/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Ear and labyrinth disorders Tube dysfunction	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Cholelithiasis	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Hypovitaminosis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Gout	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Liver steatosis	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Hypercholesterolemia	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Cholecystalithiosis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Endocrine disorders Enlarged thyroid gland	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Eye disorders Cataract	3.0% 4/135 • Number of events 4 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Eye disorders Retinal rupture	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Eye disorders PCO	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Groin pain due to tendinopathy	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Deteriorating pain in groin right hip	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Immune system disorders Slightly higher CRP	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Immune system disorders Rheuma	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Heterotopic ossification of hip seen on xray	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Peri-articular ossification	2.2% 3/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Worsening of peri-articular ossification	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Discomfort lateral aspect hip	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Occasional mild discomfort in groin and hip	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Infections and infestations Cellulitis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Infections and infestations Herpes	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Infections and infestations Infection surgical wound	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Infections and infestations Flu	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Injury, poisoning and procedural complications Patient fell down	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Injury, poisoning and procedural complications Allergic reaction (food)	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Psychiatric disorders Dementia	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Psychiatric disorders Depression	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Psychiatric disorders Memory decline	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Psychiatric disorders Anxiety	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Blood and lymphatic system disorders Oedema legs	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Bursitis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Chondrocalcinosis menisci	0.74% 1/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Elastofibroma	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Inflammation bursa iliopsoas	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Fibrostosis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Impingement	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Infection tendon	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders muscular reumatism	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Muscle weakness	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Muscle tear	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Menisci tears	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Rupture tendon	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Sprain	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Symphysitis of pubis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Tendinopathy	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Tendinitis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Tendinosis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Tendostosis	1.5% 2/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Trochanteric bursitis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Tennis elbow	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Trochanteritis	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Nervous system disorders Radicular pain in lower extremity (Ischias)	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Nervous system disorders Sleep apnea	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Nervous system disorders Neuropatic pain	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Nervous system disorders Horner syndrome	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Nervous system disorders Dizziness cervical origin	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Unexplained bruising on lower left calf	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Afonia	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Fever and color wound right leg	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Fever	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Unexplained pain of operated hip	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Pain	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Iliopsoas bursitis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Chest pain	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Headache	3.0% 4/135 • Number of events 5 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Pain in hip	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Breast pain	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Product Issues Adverse reaction to metal debris	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Reproductive system and breast disorders Prostatitis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Reproductive system and breast disorders Benigne prostate hypertrophy	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Reproductive system and breast disorders Epydimitis left testes	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Sore throat	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Asthma	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Dyspnoe	2.2% 3/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Bronchitis	2.2% 3/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Respiratory, thoracic and mediastinal disorders Sinusitis	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Arthritis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Arthrosis	14.1% 19/135 • Number of events 28 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Capsular irritation around left hip and groin pain	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Cervicalgia	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Cervicobrachialgie	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Chondromalacie	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Contusion	6.7% 9/135 • Number of events 9 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Discopathy	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Cyst	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Dupuytren dig 5 right hand	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Fracture	3.0% 4/135 • Number of events 4 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Hallux rigidus	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Hallux Valgus	1.5% 2/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Osteoarthritis	3.7% 5/135 • Number of events 6 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Heel spur	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Lumbalgie	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders osteoporosis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Back pain	3.7% 5/135 • Number of events 5 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Shoulder pain	3.7% 5/135 • Number of events 5 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Painful metatarsophalangeal joint	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Pain in hip	3.0% 4/135 • Number of events 4 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Ankle pain	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Cervical pain	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Pain in foot	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Pain in jaw	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Pins and needles left leg	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Spinal stenosis	2.2% 3/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Cervical vertebrae stenosis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Knee pain	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Active keratosis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Solar Keratosis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Eczema	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Dermatochalasis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Actinic keratosis	1.5% 2/135 • Number of events 2 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Exostosis in the heel	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Wound on left hip - along previous surgery wound	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Wound right knee and lower leg due to a fall	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Erythema due to bites of insects	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Removal birthmark nose	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Skin tear left arm due to a fall	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Cut left little finger	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Panniculitis right knee	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Wound left index finger	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Subunguaal hematoma right finger (3)	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Wound nose due to a fall	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Psoriasis	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Seborrheic keratosis irritation	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Skin and subcutaneous tissue disorders Keratosis actinica	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Prolonged chest pain	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
General disorders Intermittent flare ups of neck pain and right arm pain	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Slight stiffness in right hip	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Ear and labyrinth disorders Benigne paroxysmale positionings vertigo (BPPV)	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Musculoskeletal and connective tissue disorders Trochanteritis right hip	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Renal and urinary disorders Urinary tract infection	2.2% 3/135 • Number of events 4 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Renal and urinary disorders Cystitis acute	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Renal and urinary disorders Ovarium cyste	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Renal and urinary disorders Prostate hypertrophy	2.2% 3/135 • Number of events 3 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Renal and urinary disorders Haematuria (asymptomatic)	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign tumor tonsilla	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal/colon cancer	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningeoma	0.74% 1/135 • Number of events 1 • Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years. All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.

Additional Information

Fleur Derdeyn, Principal Clinical Study Manager

Smith + Nephew

Phone: 0032 497 60 20 32

Email: fleur.derdeyn@smith-nephew.com

Results disclosure agreements

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

Restriction type: LTE60