SELF CENTERING 1035-47-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SELF CENTERING BI-POLAR HEAD 28mm ID 47mm OD · Class 2 · Implant
All models of SELF CENTERING (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Self Centering bipolar hip head is an implant used in partial hip replacement surgery. The 49 reports mostly describe the hip joint coming apart or dislocating after surgery, along with infection and pain; several describe surgeons having to revise or swap out the implant. There were 48 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10603295003373), received between Jul 21, 2017 and Feb 23, 2026 — classified as 48 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem22
- Device Dislodged or Dislocated20
- Insufficient Device Problem Information6
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Joint Dislocation21
- No Code Available15
- Unspecified Infection12
- Pain8
- Not Applicable3
- Discomfort2
- Insufficient Information2
- Joint Laxity2
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAD DISLOCATED TWICE SINCE HIP HEMIARTHROPLASTY. CONVERSION TO TOTAL HIP WITH MULTIHOLE GRIPTION CUP, 7 SCREWS AND +4 10 DEGREE LINER. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24414328 ↗InjuryNov 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO ADVERSE EFFECTS OR CONSEQUENCES FOR THE PATIENT.
Patient problems: Joint Dislocation
MAUDE report 23584575 ↗InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THERE WAS DISLOCATION OF HIP. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 23290405 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SWAPPED SELF-CENTERING BIPOLAR AND FEMORAL HEAD AFTER DRAINING SURGICAL SITE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Fluid Discharge
MAUDE report 23289937 ↗InjuryMay 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON CHANGED OUT HEAD ALL SIZE. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21944656 ↗InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RIGHT HEMI-ARTHROPLASTY REVISION TO PROSTALAC BECAUSE OF INFECTION. NO ADVERSE EFFECTS OR SURGICAL DELAYS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21576732 ↗InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATING NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.
Patient problems: Unspecified Infection
MAUDE report 21464929 ↗InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS INFECTED. DOCTOR DID WASHOUT AND HEAD EXCHANGE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21150124 ↗InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A PELVIC FRACTURES AND THE SURGEON PLATED THE FX AND CONVERTED TO A TOTAL HIP ARTHROPLASTY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Bone Fracture(s)
MAUDE report 19732289 ↗InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 18721922 ↗InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 18443595 ↗InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD HEMI HIP ON (B)(6) 2023. PATIENT WAS PRESENTED WITH INFECTION. SURGEON DID IRRIGATION AND DEBRIDEMENT (I&D) WITH BI-POLAR AND HEAD EXCHANGE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 18230335 ↗InjuryNov 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT FELL POST OP AND DISLOCATED. STEM WAS SWAPPED FOR CEMENTED CONSTRUCT SINCE THE FALL LOOSENED THE STEM SHORTLY AFTER SURGERY. THE LOOSENING INTERFACE OF STEM IS NON-CEMENTED, CEMENT MANUFACTURER IS UNKNOWN. CONSTRAINED TOTAL HIP WAS IMPLANTED TO AVOID FUTURE DISLOCATIONS. DOI: (B)(6) 2023; DOE: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 18135811 ↗InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO CONVERSION OF HEMI HIP TO TOTAL. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 17152452 ↗MalfunctionJan 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT SHELLS WILL NOT STAY ON HEAD.
Patient problems: Insufficient Information
MAUDE report 16121882 ↗InjuryDec 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION FOR PREVIOUS GREATER TROCHANTER FRACTURE. SURGEON REMOVED HEMI TO IMPLANT ACETABULAR CUP. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 15970153 ↗InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE LOOSE BIPOLAR CONVERT TO THA. DOI: UNKNOWN DOR: (B)(6) 2022 AFFECTED SIDE: LEFT HIP.
Patient problems: Discomfort; Pain
MAUDE report 15896970 ↗InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD CONVERSION FROM HEMI TO TOTAL HIP DUE TO STABILITY ISSUES. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 15393737 ↗InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF PFR AND BIPOLAR HEAD DUE TO INFECTION. WASHED OUT AND REIMPLANTED NEW COMPONENTS. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 15249298 ↗InjuryAug 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE HEAD WAS REPLACED DUE TO DISLOCATION. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 15155924 ↗InjuryMar 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION COMPLETED DUE TO DISLOCATION. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 13904651 ↗InjuryMar 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS MULTIPLE DISLOCATIONS. CONVERTED TO A TOTAL HIP. DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (RIGHT HIP).
Patient problems: Joint Dislocation
MAUDE report 11392980 ↗InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED FOR INFECTION. EXPLANTED THE BIPOLAR HEAD AND 28MM +1.5 COCR HEAD. PROCEEDED WITH A WASHOUT. IMPLANTED A NEW BIPOLAR HEAD AND 28 +8.5 COCR HEAD.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11237982 ↗InjuryJan 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE HIP REVISION OF CEMENTED BIPOLAR CONSTRUCT DUE TO INSTABILITY AND DISLOCATION. STEM WAS REMOVED AND A NEW STEM WAS CEMENTED IN PLACE. THIS WAS IMPLANTED WITH A COMPETITORS DUAL MOBILITY CUP CONSTRUCT. DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (LEFT HIP).
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 11237939 ↗InjuryDec 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO CONTINUOUS DISLOCATION. CONVERTED TO TOTAL HIP. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 10984645 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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