SELF CENTERING 1035-42-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SELF CENTERING BI-POLAR HEAD 28mm ID 42mm 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 Orthopaedics bipolar hip head (self-centering head used in partial hip replacement) is an implant that fits into the hip socket. Reports mostly describe the hip coming apart or dislocating after surgery, with the plastic liner or polyethylene ring breaking into pieces in some cases, plus pain and difficulty fitting the part. There are 33 reports, no deaths and 20 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
- 33
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295003328), received between Dec 20, 2017 and Apr 14, 2026 — classified as 20 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (15 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 Dislocated15
- Adverse Event Without Identified Device or Use Problem5
- Difficult to Insert4
- Fitting Problem3
- Fracture3
- Noise, Audible3
- Appropriate Device Problem Term/Code Not Available1
- Device Damaged Prior to Use1
Patient problems
- Joint Dislocation11
- Pain6
- No Code Available5
- No Consequences Or Impact To Patient5
- Not Applicable4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Insufficient Information3
- Joint Laxity3
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2026Fracture; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS A BREAK AT THE POLYETHYLENE CLAMPING MECHANISM (RING) OF THE PROSTHETIC DOME.
Patient problems: Joint Dislocation
MAUDE report 24871192 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 24257658 ↗InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2025. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN.
Patient problems: Pain
MAUDE report 21875516 ↗InjuryJan 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21251776 ↗InjuryOct 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION FOR AN UNKNOWN REASON. SURGEON TRIED TO CLOSE REDUCE IT WITHOUT SUCCESS. SURGEON OPENED AND INCREASED HEAD LENGTH TO A +5 28MM HEAD. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP. ADDITIONAL EVENT INFORMATION: HEMIARTHROPLASTY HIP WAS REVISED TO ADDRESS HIP DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 20363965 ↗InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DOCTOR NEEDED TO REMOVE THE BI-POLAR HEAD AND METAL HEAD DUE TO INFECTION SUSPECTED. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 18686135 ↗MalfunctionOct 24, 2023Fracture; Fracture
IT WAS REPORTED THAT THE SELF CENTERING PE LINER BROKE INTO 3 PIECES.
Patient problems: Insufficient Information
MAUDE report 17997091 ↗InjuryJun 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HIP HAD DISLOCATED AFTER THEIR HEMIARTHROPLASTY. THE SURGEON SAID IT WAS REALLY TIGHT TO GET BACK IN, SO HE DECIDED TO REMOVE ALL THE COMPONENTS AND CHANGE TO A TOTAL HIP WITH A CONSTRAINED LINER. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 17060086 ↗InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PC WAS CREATED TO CAPTURE THE ALLEGATION OF INCREASE PAIN AND INSTABILITY AFTER FIRST REVISION. DOI: (B)(6) 2022. DOE: (B)(6) 2022. LEFT HIP.
Patient problems: Discomfort; Fatigue; Joint Laxity; Pain; Unspecified Tissue Injury
MAUDE report 16724053 ↗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 16121993 ↗MalfunctionJun 28, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT 41MM BIPOLAR SHELL WAS USED DURING IMPLANTING. UPON SECURING THE BIPOLAR SHELL TO THE FEMORAL HEAD IMPLANT, SURGEON NOTICED A GAP BETWEEN THESE 2 IMPLANTS WHICH DOES NOT TYPICALLY HAPPEN IN OTHER BIPOLAR CASES. SURGEON DECIDED TO TEST THE SAME USING A BIPOLAR SHELL OF A DIFFERENT SIZE (42MM), AND A DIFFERENT FEMORAL HEAD IMPLANT OF THE SAME SIZE. THE SAME TEST WAS CONDUCTED UPON IMPLANTING AND THE BIPOLAR SHELL STILL LIFTED OFF THE FEMORAL HEAD IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14842714 ↗InjuryApr 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO LOOSENING AT BONE TO IMPLANT INTERFACE AND DISENGAGED OF THE BIPOLAR HEAD TO POLY INSERT IN THE POST-OP EVENT. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.
Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Cellulitis; Deformity/ Disfigurement; Hearing Impairment; Insufficient Information; Joint Dislocation; Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema; Tinnitus; Vertigo
MAUDE report 14192284 ↗InjuryNov 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THIS PATIENT FELL IN REHAB AND DISLOCATED HER HIP. DR. (B)(6) WAS UNABLE TO REDUCE IT WITHOUT DOING AN OPEN REDUCTION. HE WANTED TO INCREASE HER BIPOLAR HEAD SIZE TO A 43MM TO INCREASE STABILITY. AFTER TRIALING AND PUT HER THROUGH A RANGE OF MOTION IT WAS NOTED TO BE STABLE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 12820767 ↗InjuryMay 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE SURGERY TIME WAS EXTENDED BECAUSE THE WHOLE SURGERY (45 MINUTES) WAS TO RETRIEVE THE BROKEN PART AND IMPLANT A NEW FEMORAL AND BIPOLAR HEAD.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11891719 ↗MalfunctionJan 7, 2021Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE BIPOLAR SHELL COMPONENT WAS ASSEMBLED ON THE BACK TABLE AND THE TECH. NOTICED THE 28 MM INNER HEAD WOULD ROTATE FREELY AS IN IT WAS STIFF. THE SURGEON AGREED THERE WAS SOMETHING WRONG WITH IT SO WE OPENED ANOTHER BIPOLAR SHELL AND 28 MM HEAD WHICH WAS CONSTRUCTED AND IMPLANTED WITH NO ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11131607 ↗InjuryDec 17, 2020Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible
VOLUNTARY REPORT RECEIVED UNDER MW5097266. IT WAS REPORTED THAT PATIENT SUFFERED A SUBCAPITAL FRACTURE OF HER RIGHT HIP. BIPOLAR HIP PLACED ON 2020. THE BIPOLAR HIP ASSEMBLY FAILED AND WAS REMOVED ON 2020. IT WAS REPLACED WITH ANOTHER DEVICE. THE SECOND DEVICE FAILED AND WAS REPLACED ON 2020. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation; Pain
MAUDE report 11026999 ↗InjuryDec 11, 2020Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible
VOLUNTARY REPORT RECEIVED UNDER MW5097267. IT WAS REPORTED THAT THE PATIENT SUFFERED A SUBCAPITAL FRACTURE OF HER RIGHT HIP. BIPOLAR HIP PLACED IN 2020. THE BIPOLAR HIP ASSEMBLY FAILED AND WAS REMOVED ON 2020. IT WAS REPLACED WITH ANOTHER DEVICE. THE SECOND DEVICE FAILED AND WAS REPLACED IN 2020. DOI: (B)(6) 2020. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation; Pain
MAUDE report 10992434 ↗InjuryOct 23, 2020Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible
IT WAS REPORTED THE PATIENT HAD TO BE REVISED AGAIN BECAUSE THE PLASTIC LINER DISASSOCIATED FROM THE BIPOLAR SHELL. PATIENT HAD COMPLAINED OF A CLICKING NOISE AND AN X-RAY SHOWED THE DISASSOCIATION. PATIENT WAS REVISED TO A UNIPOLAR CONSTRUCT. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.
Patient problems: No Code Available
MAUDE report 10726177 ↗InjurySep 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD A BIPOLAR MOD ENDO INSERTED ON (B)(6) 2020. ON (B)(6) 2020 AN X-RAY SHOWED THAT IT HAD DISLOCATED. SO THE DOCTOR DID A REVISION HIP SURGERY ON (B)(6) 2020. UPON REVISION SURGERY IT WAS NOTED THAT THE MOD ENDO PLASTIC WAS BROKEN. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.
Patient problems: No Code Available
MAUDE report 10568098 ↗MalfunctionSep 14, 2020Difficult to Insert; Difficult to Insert
LEFT HIP HEMIARTHROPLASTY. DEFECT WAS FOUND BY SURGEON DURING IMPLANTATION. POLY WAS REMOVED BY A NURSE GENTLY WITH A RIGHT ANGLED FORCEPS. DURING IMPLANTATION, POLY WASN'T ENGAGING TO THE +1.5 28MM FEMORAL HEAD. THE "RING" AROUND THE POLY OF THE BIPOLAR HEAD WAS FOUND TO BE LOOSE. IMPLANT WAS NOT USED IN PATIENT. A NEW IMPLANT WAS OPENED. SURGERY WENT WELL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10529200 ↗InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS INFECTED JOINT SPACE. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT SIDE.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10338986 ↗InjuryJan 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION OF THE BIPOLAR SHELL POLY FROM THE SHELL. CONVERSION OF BIPOLAR HIP TO TOTAL. DOI: (B)(6) 2017; DOR: (B)(6) 2019, (LEFT HIP).
Patient problems: No Code Available
MAUDE report 9540256 ↗MalfunctionNov 7, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE 28 HEAD WOULD NOT MOVE FREELY IN BIPOLAR HEAD.
Patient problems: Not Applicable
MAUDE report 9292780 ↗MalfunctionApr 8, 2019Difficult to Insert; Difficult to Insert
CLASP LOOSE. IT WAS REPORTED THAT THE PATIENT WAS WITH FEMORAL NECK FRACTURE, DURING THE HEMIARTHROPLASTY, WHEN INSTALLED OF THE BIPOLAR CUP, THE SURGEON FELT THAT THE POLYETHYLENE CLASP WAS LOOSE AND WITH THE RISK OF PROLAPSE, AND HE HAD THIS CONCERN, BUT RESERVED THIS CUP,THE FEMORAL PROSTHESIS WAS IMPLANTED STABLY AND THE REPOSITIONED WELL, AND THEN USED SUTURE TO SEW THE WOUND AND COMPLETE THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8493352 ↗MalfunctionJan 25, 2019Device Damaged Prior to Use; Device Damaged Prior to Use
WHILE IN THE SURGERY THAT THE PLASTIC INSERT WHEN OPENED ON THE STERILE FIELD CAME OUT IN TWO PIECES. THE REPRESENTATIVE OR SURGEON HAD NOT SEEN THIS IN THE PAST SO DECIDED TO OPEN ANOTHER IMPLANT OF THE SAME SIZE. THEY THOUGHT THAT IT MAY HAVE BEEN DUE TO THE SIZE OF THE IMPLANT SINCE IT WAS A SMALLER SIZE THAT IS NOT COMMONLY USED.
Patient problems: Not Applicable
MAUDE report 8277145 ↗
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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