SELF CENTERING 1035-53-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SELF CENTERING BI-POLAR HEAD 28mm ID 53mm 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 metal ball component used in partial hip replacement surgery. The 27 reports mostly describe hip infections that led to further surgery to wash out or swap out the implant, along with hip dislocation, pain after falls, and one case where the implant was found unstable. Reports mention 24 injuries and no deaths. There are no recalls naming 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
- 26
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295003434), received between Aug 18, 2017 and Apr 30, 2026 — classified as 23 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 Problem14
- Device Dislodged or Dislocated5
- Insufficient Device Problem Information5
- Appropriate Device Problem Term/Code Not Available1
- Device Expiration Issue1
- Expiration Date Error1
Patient problems
- Unspecified Infection11
- Joint Dislocation4
- Fall3
- No Code Available3
- Not Applicable3
- Pain3
- Damage to Ligament(s)2
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED A HIP INFECTION. SURGEON WASHED THE HIP OUT AND REPLACED THE HEAD BALL COMPONENTS OF THE HEMI HIP. INFECTION WAS PRESENT. DOI: UNKNOWN. DOR: ON (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 25052533 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED FOR IRRIGATION AND DEBRIDEMENT WITH HEAD EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 24009720 ↗InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT FELL. A LARGE HEMOTOMA WAS REMOVED. HEAD AND CUP WERE SWAPPED. AFFECTED SIDE: RIGHT.
Patient problems: Fall; Hematoma
MAUDE report 23703739 ↗InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO UNSTABLE IMPLANT. DOI: UNKNOWN. DOR: (B)(6) 2024 . AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 21142585 ↗InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD AN INFECTION. THEY NEEDED A WASH OUT AND A BIPOLAR EXCHANGE. DOI: (B)(6) 2024, DOR: (B)(6) 2024 , AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 20362985 ↗InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED REVISION WAS COMPLETED DUE TO WORN ACETABULAR CARTILAGE. PATIENT WAS CONVERTED TO A TOTAL HIP. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.
Patient problems: Damage to Ligament(s)
MAUDE report 19647412 ↗InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PHYSICIAN NOTED DRAINAGE AT THE INCISION SITE, SO DECIDED TO PERFORM AN I&D AND SWITCH OUT THE BIPOLAR AND 28 HEAD. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Fluid Discharge
MAUDE report 18650564 ↗InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED A FEW DAYS AGO WITH A POSSIBLE JOINT INFECTION, SURGEON ELECTED TO WASH OUT AND CHANGE THE HEAD AND LINER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 16626596 ↗MalfunctionJan 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT SHELLS WILL NOT STAY ON HEAD.
Patient problems: Insufficient Information
MAUDE report 16130676 ↗InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A HEMIARTHROPLASTY ON (B)(6) 2021. THE SURGEON STATED THAT HE FELL A FEW DAYS AFTER AND DISLOCATED, THE PATIENT HAS PARKINSON¿S. THE SURGEON ELECTED TO REDUCE AND CHANGE THE BIPOLAR HEAD ON (B)(6) 2021. THE PATIENT WAS PLACED IN A BRACE TO STABILIZE THE LEG BUT THE SURGEON SAID HE WASN¿T WEARING IT CONSISTENTLY. THE SURGEON SAID HE FELL AGAIN AROUND THE END OF SEPTEMBER AND THAT HE BELIEVED THE PATIENT TO POSSIBLY BE INFECTED. THE SURGEON ELECTED TO REMOVE ALL THE IMPLANTS AND LEAVE THE PATIENT WITH A GIRDLE STONE AND TEY TO CLEAR THE INFECTION. DOI: (B)(6) 2021 (STEM), (B)(6) 2021 (BIPOLAR HEAD AND FEMORAL HEAD). DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Unspecified Infection
MAUDE report 12636772 ↗InjuryOct 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD PARKINSON¿S AND FELL AND DISLOCATED HIS HIP. THE SURGEON ELECTED TO LENGTH THE BALL TO TIGHTEN THE JOINT. DOI: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 12568079 ↗InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURGEON EXPLAINED THE PATIENT WAS FEELING SOME DISCOMFORT IN THEIR RIGHT HIP. SHE BELIEVED IT TO BE DUE TO THE WEARING OF THE BIPOLAR COMPONENT ON THE PATIENT'S NATIVE ACETABULUM. THE SURGEON BELIEVED IT WOULD BE BEST TO CONVERT THIS PATIENT'S BIPOLAR INTO A TOTAL HIP. THE BIPOLAR COMPONENT AND 28MM HEAD WERE REMOVED, ALLOWING AMPLE ROOM FOR THE SURGEON TO REAM OUT THE ACETABULUM. AFTER REAMING THE ACETABULUM, A 54MM GRIPTION MULTI HOLE CUP WAS IMPLANTED. A TRIAL REDUCTION WAS PERFORMED AFTER IMPLANTING A 54X36MM +4 10 DEGREE LINER. THE PATIENT HAD LOST SOME LENGTH, SO A +15.5 WAS TRIALED AND FOUND TO BE SATISFACTORY. THE REAL HEAD WAS OPENED AND IMPLANTED. THE HIP WAS REDUCED AND FOUND TO BE STABLE. THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT HIP.
Patient problems: Discomfort
MAUDE report 11116621 ↗InjuryDec 29, 2020Adverse 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) 2020, DOR: (B)(6) 2020, RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11087380 ↗MalfunctionSep 15, 2020Expiration Date Error; Expiration Date Error
(B)(6) HAS IMPLANTED, THE (B)(6) 2020, A PRODUCT WITH AN EXPIRATION DATE ON JULY 2020.
Patient problems: Insufficient Information; No Code Available
MAUDE report 10536478 ↗InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD PRIOR BI-POLAR HEMI ARTHROPLASTY WHICH BECAME INFECTED. SURGEON PERFORMED I&D OF THE HIP, WITH SWAP OF FEMORAL HEAD COMPONENTS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10269119 ↗InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9088461 ↗InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
PATIENT WAS REVISED TO ADDRESS PAIN WITH LOSS OF ACETABULAR CARTILAGE DUE TO FAILED RIGHT HEMIARTHROPLASTY. REVISION NOTES REPORTED WEAR TO THE ACETABULUM. DOI: (B)(6) 2004 - DOR: (B)(6) 2010; (RIGHT HIP).
Patient problems: Burning Sensation; Damage to Ligament(s); Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Not Applicable; Pain; Paresthesia; Swelling; Swelling/ Edema
MAUDE report 7890852 ↗InjuryAug 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED A COUPLE WEEKS POST OP. TWO SEPARATE CLOSE REDUCTIONS WERE DONE AND OPEN REDUCTION WAS DONE AND DETERMINED THAT THE HIP WAS UNSTABLE. THE PATIENT WAS CONVERTED TO A TOTAL HIP TO ACHIEVE A STABLE HIP JOINT. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 7818644 ↗InjuryJun 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS REVISED TO ADDRESS INFECTION OF HEMIARTHROPLASTY. I&D WITH BIPOLAR HEAD EXCHANGE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Not Applicable; Unspecified Infection
MAUDE report 7562077 ↗InjuryMay 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
DER STATES THAT THE PATIENT HAD LEFT HIP PAIN AND DOCTOR WANTED CONVERT FROM A BIPOLAR TO A TOTAL HIP. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.
Patient problems: Not Applicable; Pain
MAUDE report 7486631 ↗MalfunctionJan 11, 2018Device Expiration Issue; Device Expiration Issue
THE SIZE 53 BIPOLAR IMPLANT HAD AN EXPIRATION DATE OF (B)(6) 2017. THE SURGEON WAS INFORMED IMMEDIATELY. THE SURGEON CHOSE TO MOVE FORWARD WITH THE EXPIRED IMPLANT. DOE: (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7181783 ↗InjuryJan 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 7177883 ↗InjuryJan 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017; DOR: (B)(6) 2017. LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 7164810 ↗InjuryJan 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017, DOR: (B)(6) 2017, LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 7163597 ↗InjuryNov 20, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 7047609 ↗
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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