SELF CENTERING 1035-54-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SELF CENTERING BI-POLAR HEAD 28mm ID 54mm 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 implant is used to replace part of the hip joint. The 25 reports mostly describe hip dislocations, infections, and difficulty fitting or inserting components, sometimes requiring revision surgery; they include 21 injuries and no deaths. No recalls name this device, and reports rose from 0 in the previous 12 months to 4 in the latest 12 months.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295003441), received between May 15, 2018 and Jul 7, 2026 — classified as 21 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 Problem13
- Device Dislodged or Dislocated6
- Difficult to Insert4
- Insufficient Device Problem Information2
Patient problems
- Unspecified Infection7
- Joint Dislocation6
- Insufficient Information3
- No Code Available3
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Joint Laxity2
- Not Applicable2
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT DISLOCATED A BIPOLAR AND REVISED TO AN EMPHASIS DUAL MOBILITY. WHEN TRYING TO TAKE THE BIPOLAR HEAD OFF THE STEM, THE STEM WAS DISLODGED. THERE WAS NO FAILURE ON THIS PART OF THE IMPLANT. IT WAS NOTED THE CEMENT USED WAS NOT DEPUYSYNTHES CEMENT. DOI: (B)(6) 2026. DOR: (B)(6) 2026 AFFECTED SIDE: LEFT.
Patient problems: Joint Dislocation
MAUDE report 25735827 ↗InjuryMay 11, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S BIPOLAR DISLOCATED, SO THE SURGEON PUT IN A CONSTRAINED LINER. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 25138106 ↗InjuryApr 11, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR DISLOCATION AND DISSOCIATION OF BIPOLAR HEAD. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 24851382 ↗InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT IS QUITE SICK AND HAS SOME INCISIONAL DRAINAGE THAT THE SURGEON DIDN'T LIKE. HE ELECTED TO WASHOUT AND CHANGE MODULAR COMPONENTS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fluid Discharge
MAUDE report 23887782 ↗MalfunctionAug 21, 2024Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT PATIENT WAS REVISED. SURGEON TRIALED WITH A 54MM BIPOLAR HEAD AND A 28MM +1.5MM FEMORAL HEAD TRIAL. THOSE SIZES WERE SELECTED AND OPENED. AFTER ASSEMBLY THE SURGEON WAS NOT SATISFIED WITH THE FIT BETWEEN THE FEMORAL HEAD AND BIPOLAR HEAD. A 53MM WAS OPENED AND THEN IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 20013239 ↗InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS BEING WASHED OUT FOR INFECTION AND DR. DECIDED IT BEST TO SWAP THE BIPOLAR AND HEAD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2024. DOR:(B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 19828248 ↗InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS BROUGHT BACK TO SURGERY DUE TO AN INFECTION IN THE SOFT TISSUE IN THE AREA OF THE HIP INCISION. AN IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED. THE ONLY IMPLANTS REMOVED WERE THE BIPOLAR AND THE HEAD BALL. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE : RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 18579334 ↗MalfunctionJul 19, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT WHITE PLASTIC INSIDE BIPOLAR DIDN¿T SEEM TO FIT. SURGEON WOULD NOT IMPLANT IT. SURGICAL DELAY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17352582 ↗InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT HIP WASH OUT WAS PERFORMED FOR UNKNOWN REASON. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17118599 ↗InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS UNSTABLE SO THE SURGEON REPLACED THE 8.5 HEAD WITH A 12 HEAD AND A NEW BIPOLAR HEAD. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 16157690 ↗InjuryDec 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION COMPLETED DUE TO DISLOCATION, HEMI CONVERSION TO TOTAL. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 16068913 ↗InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD I&D DUE TO POSSIBLE INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 15897834 ↗InjuryJul 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO THE CONVERSION OF HEMI TO TOTAL DUE TO RECURRING DISLOCATION, IE, THREE TIMES IN THE LAST 10 DAYS. STEM WAS NOT REVISED. NO ADDITIONAL INFORMATION. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 15092941 ↗MalfunctionJun 15, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE 54MM BIPOLAR SHELL WAS OPENED AND WHEN IT WAS ASSEMBLED WITH THE FEMORAL HEAD IT WAS OBSERVED THAT THE PLASTIC LINER DID NOT FIT TIGHTLY WITHIN THE METAL SHELL. THERE WAS SOME ¿PLAY¿ AS THE LINER MOVED INSIDE OF THE SHELL. SURGEON HAD AN EXTRA 54MM BIPOLAR COMPONENT THAT WAS OPENED AS THE SURGEON WAS CONCERNED THAT THERE MAY BE A DISASSOCIATION IF THIS COMPONENT WAS USED. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOE: UNKNOWN, AFFECTED SIDE: LEFT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14695266 ↗InjuryMay 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAS PARKINSON¿S AND FELL AND DISLOCATED THE HIP. SURGEON ELECTED TO CHANGE THE BIPOLAR HEAD TO 1 SIZE SMALLER AND THE HEAD BALL TO A 15.5 FOR MORE STABILITY. THERE IS NO REPORTED LOOSENING. UNKNOWN IF ANY SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.
Patient problems: Fall; Joint Dislocation; Joint Laxity
MAUDE report 14461239 ↗InjuryMar 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON DECIDED TO REMOVE ALL IMPLANTS AND FIGHT THE INFECTION WITH ANTIBIOTICS AND ANTIBIOTIC BEADS. HE PLANS TO RETURN AND RE IMPLANT. THERE IS NO MORE INFORMATION. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 13684928 ↗InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO I&D. DOI: UNKNOWN ; DOR: (B)(6) 2021 ; (RIGHT HIP).
Patient problems: Unspecified Infection
MAUDE report 13190291 ↗InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021 DOR: (B)(6) 2021 AFFECTED SIDE: RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11843440 ↗InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS AN I & D FOR INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11406802 ↗InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS PAIN. THE SURGEON REMOVED THE BIPOLAR CUP AND REPLACED IT WITH A PINNACLE GRIPTION CUP. THE HEAD WAS REPLACED AS WELL. DOI: 2014. DOR: (B)(6) 2019. (LEFT HIP).
Patient problems: No Code Available; Pain
MAUDE report 8940200 ↗InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD PAINFUL LEFT HIP HEMI. DOI: UNK; DOR: (B)(6) 2019; LEFT HIP.
Patient problems: No Code Available; Pain
MAUDE report 8604353 ↗InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS PAIN. RIGHT HIP.
Patient problems: No Code Available; Pain
MAUDE report 8557735 ↗MalfunctionMar 21, 2019Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE PLASTIC PORTION OF BIPOLAR HEAD WOULD NOT FULLY ENGAGE IN METAL PORTION.
Patient problems: Not Applicable
MAUDE report 8440719 ↗InjuryJul 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2018; DOR: (B)(6) 2018 UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 7673392 ↗InjuryMay 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO INDICATED THAT THE SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH NEW TOTAL HIP. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP. NO SURGICAL DELAY.
Patient problems: Not Applicable; Unspecified Infection
MAUDE report 7513749 ↗
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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