SELF CENTERING 1035-44-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SELF CENTERING BI-POLAR HEAD 28mm ID 44mm 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 component used in partial or total hip replacement. The 58 reports mostly describe the head dislocating or coming apart after surgery, along with hip infections, pain, and difficulty fitting the liner into the head during the operation; some mention the head fracturing. 46 injuries and no deaths were reported, and 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
- 60
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10603295003342), received between Aug 8, 2017 and Sep 14, 2026 — classified as 48 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (26 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 Dislocated26
- Adverse Event Without Identified Device or Use Problem21
- Difficult to Insert8
- Insufficient Device Problem Information4
- Fracture2
- Device Damaged Prior to Use1
- Loose or Intermittent Connection1
Patient problems
- Joint Dislocation23
- Unspecified Infection11
- No Clinical Signs, Symptoms or Conditions8
- No Code Available8
- Pain8
- Insufficient Information4
- Not Applicable3
- Bone Fracture(s)2
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Patient was revised for infected bipolar hip. Head was exchanged.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown Hip.
Patient problems: Unspecified Infection
MAUDE report 50755947 ↗InjurySep 8, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50676043 ↗InjuryMay 19, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT BIPOLAR DISLOCATION; REVISED TO A ACETABULAR CUP AND +4/10 LINER NO ALLEGATION AGAINST IMPLANTS. AFFECTED SIDE-LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 25216835 ↗InjuryApr 28, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAD LEFT HIP DISLOCATION. PREVIOUS INFECTED HIP. EXPLANTED STEM, BIPOLAR HEAD AND 28+6 SROM HEAD. IMPLANTED SROM STEM WENT UP TO A +12. DOWNSIZED BIPOLAR HEAD TO 43X28. IMPLANTED 28+3 SROM HEAD.
Patient problems: Joint Dislocation
MAUDE report 25013341 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD AN INFECTED HIP IN WHICH MULTIPLE WASHOUTS DID NOT CLEAR THE INFECTION. SURGEON REMOVED IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 24769100 ↗InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT I&D HEAD EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 24489523 ↗MalfunctionJan 15, 2026Difficult to Insert
IT WAS REPORTED THAT SURGEON HAD ISSUES GETTING LINER TO BE SEATED INTO THE HEAD. CAUSED SOME POLY WEAR. OPTED FOR NEW COMPONENTS. THERE WAS A DELAY OF LESS THAN TWO MINUTES. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24080399 ↗InjuryJan 14, 2026Device Dislodged or Dislocated
PATIENT REVISED FOR HIP DISLOCATION. NO FAILURE ON IMPLANT SIDE.
Patient problems: Joint Dislocation
MAUDE report 24072187 ↗InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT THE REASON FOR THE REVISION SURGERY WAS INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23535361 ↗MalfunctionSep 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE BIPOLAR POLY DID NOT LOCK INTO THE BIPOLAR SHELL APPROPRIATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23028384 ↗MalfunctionJul 28, 2025Fracture; Fracture
IT WAS REPORTED THAT THESE ITEMS BECAME BROKEN WHEN TRYING TO REMOVE TRIALS ON BACK TABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22633766 ↗InjuryJun 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT COMES BACK FOR ANOTHER DISLOCATION OF HER BIPOLAR HIP. DOCTOR PLANS TO REMOVE THE BIPOLAR CONSTRUCT AND IMPLANT A CUP FOR MORE STABILITY. HE IMPLANTED A 48 3-HOLE EMPHASIS, TWO SCREWS AND AN EMPHASIS DUAL MOBILITY LINER. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22142515 ↗InjuryMay 16, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME BACK IN WITH A DISLOCATED BIPOLAR CONSTRUCT. THE HEAD WAS ATTACHED TO THE STEM BUT THE BIPOLAR WAS DISASSOCIATED FROM THE HEAD. THE SURGEON REMOVED THE BIPOLAR AND HEAD. HE RE-IMPLANTED A 44 BIPOLAR AND 28 +12 HEAD. UNKNOWN SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 22034968 ↗InjuryMar 25, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE INNER PLASTIC RING OF BIPOLAR HEAD SHEARED OFF AND INNER HEAD DISLOCATED FROM BIPOLAR HEAD. THERE WAS A LOOSENING REPORTED AT BIPOLAR HEAD AND INNER HEAD CONSTRUCT. PATIENT WAS REVISED. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 21687149 ↗InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION AND NEEDED HEAD SWAP. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21560758 ↗InjuryJan 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISLOCATION. THE NECK LENGTH WAS INCREASED. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 21267597 ↗InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT HIP SURGERY WAS PERFORMED AND IMPLANT WAS REMOVED DUE TO NON-COMPLIANCE. THE PATIENT WAS UNABLE TO FOLLOW SIMPLE INSTRUCTIONS BELIEVED TO BE DUE TO STAGE DEMENTIA. SHE HAD DISLOCATED HER HIP AND THE DR WAS UNABLE TO RELOCATE THE HIP IN THE ER SHE WAS TAKEN TO THE OR WHERE THE DR DECIDED TO REMOVE THE IMPLANT TO HOPEFULLY PREVENT MORE COMPLICATIONS OR INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 20396048 ↗InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED DUE TO INSTABILITY. THIS PATIENT'S HIP WAS DYSPLASTIC, SO THE BIPOLAR HEAD WOULD NOT REMAIN IN PLACE. THE PATIENT'S PRIMARY BIPOLAR HEAD WAS THEREFORE REMOVED AND A STABLIZING PINNACE ACETABULAR CUP, ALONG WITH AN ALTRX LINER AND A BIOLOZ DELTA CERAMIC HEAD WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 20258583 ↗InjuryAug 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAD A PREVIOUS HEMI HIP ARTHROPLASTY WHICH DISLOCATED. PHYSICIAN OPTED TO REVISE TO TOTAL HIP ARTHROPLASTY. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 20087120 ↗InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 19974213 ↗InjuryJul 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATED HIP. DOI: UNKNOWN. DOR: (B)(4) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 19752021 ↗InjuryApr 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. A CONSTRAINED LINER WAS NEEDED FOR THE PATIENT'S SPECIFIC NEEDS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 19088540 ↗InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 18047956 ↗InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2023, DOR: OCTOBER 8, 2023, AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 17952377 ↗MalfunctionAug 1, 2023Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use
ADDITIONAL INFORMATION RECEIVED. A. WHAT WAS THE EXACT ALLEGATION AGAINST THE DEVICE? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION? THIS IMPLANT IS MADE UP OF 2 PIECES, THAT FIT TOGETHER. IN THE IMPLANT REFERRED TO IN THIS COMPLAINT, THE FITTING WAS DEFECTIVE. THERE WAS A GAP, THAT I COULDN'T BEAR TO HAVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17435873 ↗
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
- 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
- Compress® Device 178552Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 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.
How reports and recalls are matched · Editorial policy · Report an error on this page