SELF CENTERING 1035-48-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SELF CENTERING BI-POLAR HEAD 28mm ID 48mm 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 the ball-and-socket component used in partial hip replacement surgery. The 43 reports mostly describe the hip coming apart or dislocating after surgery, along with infections that required washout and revision operations, and pain or looseness in the joint. Reports include 1 death and 37 injuries. 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
- 43
- Deaths reported
- 1
- Injuries reported
- 37
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295003380), received between Aug 2, 2017 and Dec 1, 2025 — classified as 1 death, 37 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (18 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
- Device Dislodged or Dislocated18
- Adverse Event Without Identified Device or Use Problem17
- Insufficient Device Problem Information3
- Difficult to Insert2
- Device Contaminated During Manufacture or Shipping1
- Device-Device Incompatibility1
- Loose or Intermittent Connection1
- Loss of Osseointegration1
Patient problems
- Joint Dislocation18
- Unspecified Infection10
- No Code Available9
- Pain6
- Joint Laxity5
- Not Applicable3
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 23679489 ↗InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. SURGEON PERFORMED A WASHOUT AND HEAD SWAP. DOI: (B)(6) 2025; DOR: (B)(6) 2025; AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 23622621 ↗InjuryOct 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION,. THE DOCTOR REVISED STEM AND HEAD CONSTRUCT. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23416546 ↗InjuryJul 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED INDEX HEMI HIP CONSTRUCT AND IS BEING REVISED DUE TO MODE OF FAILURE BEING INSTABILITY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 22479904 ↗InjuryJun 11, 2025Adverse 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 CHRONIC INFECTION. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 22185968 ↗InjuryApr 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED AND NEEDED REVISION SURGERY TO STABILIZE. THERE WAS NO SURGICAL DELAY RELATED TO THE EVENT. AFFECTED SIDE: LEFT.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 21891414 ↗InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED AND UNDERWENT WASH OUT OF THE HIP DUE TO AN INFECTION. I&D HEMI HIP WITH HEAD AND BIPOLAR HEAD EXCHANGE. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21471056 ↗InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 19313094 ↗InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE A CONVERSION WAS HELD TO CONVERT A HEMI TO A TOTAL HIP DUE TO THE PATIENT COMPLAINING OF ACETABULUM PAIN. DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP
Patient problems: Pain
MAUDE report 19190669 ↗InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD PAIN. BIPOLAR WAS CONVERTED TO TOTAL. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT.
Patient problems: Pain
MAUDE report 18085728 ↗InjuryJun 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO INSTABILITY. HIS SURGICALLY REPAIRED BIPOLAR HIP HAD DISLOCATED THREE TIME SINCE HIS FEMORAL NECK FRACTURE REPAIR THREE WEEKS EARLIER. DURING THE REVISION PROCEDURE, THE PATIENT'S BIPOLAR HEAD AND CEMENTED STEM WERE REMOVED AND HIS HIP WAS CONVERTED TO A GIRDLESTONE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 17124745 ↗InjuryMar 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT¿S HIP KEPT DISLOCATING, SURGEON DECIDED TO REMOVE THE BIPOLAR HEAD AND PUT IN A PINNACLE CUP WITH DUAL MOBILITY IMPLANTS. IMPLANTED WAS A 50 CUP, 50/43 DUAL MOBILITY LINER, BIMENTUM LINER 22.2/43, AND A 22.225 +7 HEAD. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023 DOI:(B)(6) 2023 AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 16512317 ↗InjuryFeb 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT DISLOCATED SOME TIME BETWEEN OPERATING ROOM AND PACU. BROUGHT BACK TO REDUCE AND POSSIBLE REVISE. IT REDUCED EASILY AND REVISED WITH BIGGER BIPOLAR HEAD AND LONGER NECK LENGTH. PATIENT SEEMS STABLE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 16278412 ↗InjuryFeb 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO THE HIP UNFORTUNATELY DISLOCATED. THE SURGEON TRIED FOR A CLOSED REDUCTION AND WAS UNSUCCESSFUL. HE FELT THERE MAY BE SOME SOFT TISSUES IN THE JOINT SPACE THAT WAS CAUSING INSTABILITY OF THE BIPOLAR. WHEN OPENING THE HIP, TISSUE IMPINGEMENT WAS CONFIRMED. HE FELT THE PATIENT MAY HAVE BEEN A LITTLE SHORT AS WELL, SO HE TRIALED A 48 BIPOLAR HEAD WITH A 28 +8.5 HEAD AND FOUND THE HIP TO BE MORE STABLE. THE REAL BIPOLAR AND 28 HEAD WAS OPENED AND IMPLANTED. THE HIP WAS REDUCED AND STABILITY WAS CONFIRMED. THE CLOSING PROCESS BEGAN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation; Joint Laxity; Physical Asymmetry
MAUDE report 16277863 ↗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 16121871 ↗InjurySep 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT UNDERWENT CLOSER REDUCTION DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 15470291 ↗InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A HEMI CONSTRUCT ON (B)(6) 2022 AND IS NOW CONFIRMED FOR INFECTION. THE BIPOLAR HEMI SHELL AND 28 HEAD WERE REMOVED. THE HIP WAS AGGRESSIVELY WASHED OUT AND A NEW BIPOLAR HEMI SHELL AND FEMORAL HEAD WERE UTILIZED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE- LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 15445447 ↗InjuryAug 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED AGAIN FOR DISLOCATING. ORIGINAL SURGERY PERFORMED ON (B)(6) 2021. CONVERTED HEMI TO A THA WITH A CONSTRAINED LINER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 15174990 ↗InjuryJul 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED FOR MULTIPLE DISLOCATIONS AND LOOSENING OF ACTIS STEM AT THE NON-CEMENTED INTERFACE. NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT.
Patient problems: Joint Dislocation
MAUDE report 15105100 ↗InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 14307304 ↗InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SURGEON REVISING HIP HEMI TO CEMENT SPACER DUE TO INFECTION. HIP WAS INFECTED SO DOCTOR REMOVED ALL COMPONENTS. NO SURGICAL DELAY. DOI: (B)(6) 2016; DOR: (B)(6) 2021; RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 12802982 ↗MalfunctionOct 27, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT WHEN THE PACKAGING OF THE IMPLANT WAS OPENED, THERE WAS SEVERAL BLACK PARTICLES IN THE PACKAGING AND ON THE IMPLANT.
Patient problems: Insufficient Information
MAUDE report 12704008 ↗InjurySep 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO IMPLANT INTERFACE. REVISION OF A BIPOLAR HIP TO A TOTAL HIP DUE TO PERI-PROSTHETIC FRACTURE AND RECURRENT DISLOCATIONS. DO NOT KNOW ORIGINAL SURGERY DATE. DOI: UNKNOWN, DOR: (B)(6) 2021, (LEFT HIP).
Patient problems: Joint Dislocation
MAUDE report 12505331 ↗InjurySep 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE REVISION IS DUE TO GIRDLE STONE DUE TO INFECTION/CHRONIC DISLOCATION. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation
MAUDE report 12435115 ↗MalfunctionJan 29, 2021Difficult to Insert; Difficult to Insert
POLYETHYLENE INLAY IN SELFCENTERING METALHEAD IS NOT STABLE AND MOVES (ALSO HEARABLE). NO PATIENT HARM - IMPLANT WAS NOT CONTACT WITH PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11252480 ↗
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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