SELF CENTERING 1035-50-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SELF CENTERING BI-POLAR HEAD 28mm ID 50mm 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 a metal hip implant used in partial or total hip replacement. The 44 reports mostly describe the hip coming apart or dislocating after surgery, along with hip infections, looseness of the joint, and pain; 41 injuries and no deaths were reported. 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
- 45
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10603295003403), received between Jul 20, 2017 and Sep 1, 2026 — classified as 42 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (17 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 Problem22
- Device Dislodged or Dislocated17
- Insufficient Device Problem Information4
- Difficult to Insert2
Patient problems
- Joint Dislocation16
- Unspecified Infection16
- No Code Available11
- Joint Laxity5
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Fall2
- Hematoma1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient showed signs of infection. Doctor performed an I&D and swapped out the heads for new ones.DOI: UnknownDOR: (b)(6), 2026Affected Side: Right
Patient problems: Unspecified Infection
MAUDE report 50548016 ↗InjuryAug 31, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50521473 ↗InjuryMay 12, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT HH REVISION DUE TO DISLOCATION. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 25149445 ↗InjuryFeb 20, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS DISLOCATING . AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24400014 ↗InjuryDec 1, 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 INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 23685764 ↗InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD UNSTABLE HIP, SO WE ADDED SOME LENGTH TO INCREASE STABILITY. NOTHING WRONG WITH IMPLANTS AND NO ADVERSE SITUATION CORRESPONDING TO IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: BOTH HIP.
Patient problems: Joint Laxity
MAUDE report 23338002 ↗InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS UNSTABLE DUE TO DEMENTIA/POST OP PROTOCOL. DOI: UNKNOWN; DOR: (B)(6) 2025; AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 21642048 ↗InjuryFeb 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATED HEMI. REVISED EVERYTHING. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 21313290 ↗InjuryJun 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT DISLOCATED AND THE DR. COULD NOT REDUCE HIP. THE DR. DECIDED TO REVISE TO A MORE CONSTRAINED CONSTRUCT. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 19606550 ↗InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? RIGHT. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.
Patient problems: Joint Laxity
MAUDE report 18791385 ↗InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PLEASE CONFIRM THE SURGICAL DELAY. - NO DELAY. PLEASE CONFIRM THE AFFECTED SIDE. - LEFT.
Patient problems: Joint Laxity
MAUDE report 18788381 ↗InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
STUDY NO: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2012. DATE OF REVISION: (B)(6) 2024. (LEFT HIP). TREATMENT: HEAD AND LINER WERE REVISED.
Patient problems: Unspecified Infection
MAUDE report 18694193 ↗InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAINFUL HIP. DOI: UNKNOWN. DOR: (B)(6). AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 18005825 ↗InjuryApr 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED TWICE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 16815752 ↗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 16121834 ↗InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS PATIENT HAD A HEMI HIP PERFORMED ON (B)(6) 2022 TO TREAT A FEMORAL NECK FRACTURE. SURGEON IMPLANTED A SUMMIT CEMENTED STEM AND A 50MM BIPOLAR HEAD WITH A 28MM +1.5MM FEMORAL HEAD. THIS PATIENT WAS OPERATED ON AGAIN 10/14 DUE TO POSSIBLE INFECTION. SURGEON PERFORMED A HIP I & D AND EXCHANGED THE BIPOLAR HEAD AND 28MM FEMORAL HEAD. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 15699214 ↗InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 15486630 ↗MalfunctionSep 21, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE LINER WITHIN THE BIPOLAR HEAD DOES NOT FIT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15461293 ↗InjurySep 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS RETURNED TO SURGERY FOLLOWING A SECOND HIP DISLOCATION. THE BIPOLAR HEAD WAS REMOVED AND THE CEMENTED FEMUR WAS RETAINED AND A TOTAL HIP WAS PLACED. NO INSTRUMENT WAS BROKEN, THERE WERE NO DELAYS OR DEFICIENCIES. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 15426922 ↗InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A LEFT HEMI HIP THAT WAS INFECTED. THE SURGEON DID A WASHOUT AND SWITCHED THE BIPOLAR HEAD OUT. THE FEMORAL STEM IS WELL FIXED AND RETAINED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 15096073 ↗InjuryDec 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 13017749 ↗InjuryNov 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO FELL, DISLOCATION AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. WITH WASH OUT. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).
Patient problems: Fall; Hematoma; Joint Dislocation
MAUDE report 12833071 ↗InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DR. (B)(6) SAID THE PATIENT WAS HAVING SOME HIP PAIN, AND SHE FELT IS WAS DUE TO THE BIPOLAR IMPLANT. SHE FELT THE PATIENT WOULD BENEFIT FROM CONVERTING THE HEMI HIP TO A TOTAL HIP REPLACEMENT. THE BIPOLAR AND 28MM HEAD WERE REMOVED AND THE ACETABULUM WAS REAMED AND PREPPED FOR A 56 GRIPTION SECTOR CUP. A +4 10 DEGREE LINER WAS IMPLANTED AND A TRIAL REDUCTION WAS PERFORMED WITH A 40MM HEAD TRIAL. THE 40MM -2 WAS FOUND TO BE STABLE AND OF APPROPRIATE LENGTH. THE REAL HEAD WAS OPENED AND IMPLANTED. THE HIP WAS REDUCED, RUN THROUGH FULL RANGE OF MOTION, AND STABILITY WAS CONFIRMED. CLOSING PROCESS BEGAN. DOI: (B)(6) 2019. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 12640310 ↗InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INFECTED LEFT HIP. REMOVE BIPOLAR HEAD AND WASHOUT AND IMPLANT STIMULAN BEADS. IMPLANTED NEW BIPOLAR & FEMORAL HEAD. DOI: (B)(6) 2021, DOR: (B)(6) 2021, (LEFT HIP).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12408220 ↗InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2003, THE PRIMARY SURGERY WAS PERFORMED WITH THE STEM, HEAD AND CUP. THE PATIENT WAS IN HIS 30S AT THE TIME. ON (B)(6) 2021, THE REVISION SURGERY WAS PERFORMED DUE TO PAIN. IN THE REVISION, THE HEAD AND CUP WERE REMOVED TOGETHER. WHEN THE SURGEON TRIED TO REMOVE THE STEM, THE STEM COULDN¿T BE REMOVED. WHEN THE SURGEON GRABBED THE STEM NECK, THE STEM NECK WAS DAMAGED. THE SURGEON GAVE UP REMOVING THE STEM AND MOVE TO HEAD SELECTION, BUT THERE WERE FEW VARIATIONS OF HEADS THAT COULD BE SELECTED. THE PATIENT WAS YOUNG IN HIS 50S, BUT THE SURGEON HAD NO CHOICE BUT TO CHOOSE A METAL HEAD. THE PLACEMENT POSITION OF THE CUP ALSO NEEDED TO BE ADJUSTED ACCORDING TO THE STEM CURRENTLY IN PLACE, AND THUS, COULD NOT BE PLACED AT THE OPTIMUM POSITION. THE MOVEMENT OF THE IMPLANT IS SLIGHTLY TIGHT, WHICH IS WORRISOME. CONSEQUENTLY, OPTIMAL TREATMENT COULD NOT BE PROVIDED. THE SURGERY WAS COMPLETED WITH MORE THAN 30MINUTES DELAY. THE SURGEON COMMENTED AS FOLLOWS. WITH HEAD VARIATION, HE WAS ABLE TO PROVIDE OPTIMAL TREATMENT FOR PATIENTS WITHOUT INCREASING OPERATION TIME. ALTHOUGH IT IS A DISCONTINUED PRODUCT, IT IS THE PRESENT TIME TO MAKE A REVISION, AND IT SEEMS T
Patient problems: Pain
MAUDE report 12288679 ↗
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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