SELF CENTERING 1035-49-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SELF CENTERING BI-POLAR HEAD 28mm ID 49mm OD · Class 2 · Implant
All models of SELF CENTERING (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy self-centering bipolar hip head is an implant part used in partial hip replacement. The 24 reports that name its identifier describe the hip coming out of joint, pain and infection, often mentioning repeat surgery to replace parts or convert to a total hip, with no deaths and 21 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
- 24
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295003397), received between Aug 23, 2017 and Jan 15, 2026 — classified as 21 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated12
- Adverse Event Without Identified Device or Use Problem7
- Appropriate Device Problem Term/Code Not Available2
- Difficult to Insert1
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Joint Dislocation10
- No Code Available9
- Pain4
- Unspecified Infection4
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body Reaction1
- Inadequate Osseointegration1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT DISLOCATED, SO DOCTOR REVISED AND USED CERCLAGE WIRES. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 24084959 ↗InjuryMay 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISLOCATION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 19342889 ↗InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) PERFORMED WITH A HEAD EXCHANGE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 19231462 ↗InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO AN INFECTION. IRRIGATION AND DEBRIDEMENT WITH A BIPOLAR HEAD EXCHANGE WAS PERFORMED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 18901974 ↗InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 16831672 ↗MalfunctionApr 11, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT AFTER INSERTING ARTICUL/EZE 28MM HEAD INTO THE BIPOLAR POLY AND PLACING BOTH INTO THE BIPOLAR SHELL, THE SURGEON NOTICED A RATTLING NOISE. HE FELT AS THOUGH THE POLY DID NOT FIT PROPERLY IN THE BIPOLAR SHELL. BIPOLAR HEAD WAS SWAPPED OUT FOR A DIFFERENT ONE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16712530 ↗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 16121849 ↗InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. CONVERTED FROM A HEMI HIP TO A TOTAL HIP. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT HIP.
Patient problems: Pain
MAUDE report 11992495 ↗InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS HAVING STABILITY ISSUES A COUPLE OF WEEKS OUT FROM HER ORIGINAL SURGERY. THE SURGEON REVISED THE BIPOLAR TO A CUP AND PINNACLE DM CONSTRUCT FOR ADDED STABILITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 11486116 ↗InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11003336 ↗InjuryApr 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS MULTIPLE TIMES DISLOCATION AND HAD THE SELF CENTERING ACETABULAR COMPONENT REVISED TO AN ACETABULAR CUP/DUAL MOBILITY COMPONENT. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 9938773 ↗InjuryFeb 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2020, RIGHT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 9763962 ↗InjurySep 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED SO THE SURGEON SAW IT FIT TO SWITCH THE IMPLANT TO A UNIPOLAR HEAD AND +10MM TAPERED SPACER TO GET MORE LENGTH AND STABILITY. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 9072704 ↗InjuryJul 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAD DISLOCATED AND THE SURGEON TRIED TO DO A CLOSED REDUCTION WHERE THE STEM LOOSENED UPON DOING SO. HAD TO OPEN AND CHANGE ALL COMPONENTS. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8836828 ↗InjuryJul 10, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
MEDICAL RECORDS RECEIVED FROM LEGAL. THE PATIENT WAS REVISED BECAUSE OF PAIN AND LOOSE STEM. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGES LOOSENING OF CUP, METAL WEAR AND METALLOSIS. THE HEAD AND THE SELF-CENTERING WAS ADDED TO THE IMPACTED PRODUCT DUE TO THE PPF ALLEGATIONS. THE PATIENT UNDERWENT BIPOLAR HEMIARTHROPLASTY. THE CEMENT USED WAS A NON-DEPUY PRODUCT. DOI: (B)(6) 2003; DOR: (B)(6) 2005; (LEFT HIP) FIRST REVISION.
Patient problems: Foreign Body Reaction; Inadequate Osseointegration; No Code Available; Pain
MAUDE report 8777122 ↗InjuryJan 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8264706 ↗InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS INFECTION. HEAD EXCHANGE DONE WITH IRRIGATION AND DEBRIDEMENT.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8257446 ↗InjuryJan 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND DISLOCATION.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8222022 ↗InjuryDec 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED TO ADDRESS (B)(6) INFECTION.
Patient problems: Unspecified Infection
MAUDE report 8164062 ↗InjuryOct 26, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION OF BIPOLAR HIP CONVERSION TO TOTAL HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8009049 ↗MalfunctionAug 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
HOSPITAL IMPLANTED EXPIRED BIPOLAR IMPLANT. THIS WAS DISCOVERED AFTER THE PATIENT HAD LEFT THE OPERATING ROOM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7813562 ↗InjuryJul 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
DER STATES THAT THE BIPOLAR HEAD HAD STARTED TO MIGRATE THROUGH THE ACETABULUM. THE BIPOLAR AND HEAD WERE REMOVED. A COMPETITOR CUP WITH MDM WAS IMPLANTED AND A NEW 28 HEAD WAS PUT ON. DOI: (B)(6) 2015; (B)(6) 2018; RIGHT HIP.
Patient problems: Pain
MAUDE report 7654971 ↗InjuryJan 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS HEMI HIP MULTIPLE DISLOCATIONS, CONVERTED TO A DUAL MOBILITY. (B)(6) 2017; (B)(6) 2018; RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 7227775 ↗InjuryAug 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS REVISED TO ADDRESS INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6815436 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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