SELF CENTERING 1035-45-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SELF CENTERING BI-POLAR HEAD 28mm ID 45mm OD · Class 2 · Implant
Quick summary
This DePuy self-centering bipolar hip replacement head fits onto the femoral stem during hip surgery. The 83 reports describe the head not sitting flush or working loose, parts rattling or wobbling, hips coming out of joint, and infections needing repeat surgery: no deaths, 51 injuries and 32 malfunctions. No recalls name this device. Reports fell to 5 in the last 12 months, from 14 the year before.
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
- 84
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10603295003359), received between Sep 15, 2017 and Jul 29, 2026 — classified as 52 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (24 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem26
- Device Dislodged or Dislocated24
- Difficult to Insert19
- Fitting Problem4
- Fracture3
- Insufficient Device Problem Information3
- Misconnection2
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Joint Dislocation22
- Unspecified Infection16
- No Clinical Signs, Symptoms or Conditions15
- No Code Available15
- Pain9
- Not Applicable8
- No Consequences Or Impact To Patient7
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Bipolar head removed for washout of Right Hip. Surgeon replaced 45 bipolar head and 28+1.5 articuleze head. Bipolar head swapped out as because of potential infected hip. There was no patient complaints.Affected Side: Right Hip.
Patient problems: Unspecified Infection
MAUDE report 50068553 ↗MalfunctionMay 13, 2026Difficult to Insert
IT WAS REPORTED THAT THE IMPLANT RATTLED WHEN 28MM HEAD WAS PUT IN BUT WHEN IT WAS SWAPPED FOR ANOTHER BIPOLAR HEAD IT SEEMED TO BE FINE WITH THE SAME 28MM HEAD. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: Insufficient Information
MAUDE report 25159850 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REVISED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24590577 ↗MalfunctionMar 12, 2026Difficult to Insert
IT WAS REPORTED THAT THE BI POLAR WOULD NOT SIT FLUSH WHEN THE FEMORAL HEAD WAS INSERTED, RESULTING IN EXCESSIVE PLAY. IT WAS STATED THAT THE INNER PART OF BI POLAR HEAD WAS LOOSE. DOE: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24584162 ↗InjuryJan 22, 2026Device Dislodged or Dislocated
PATIENT HAD ORIGINAL SURGERY ON DECEMBER 28, 2025. PATIENT GOT REVISED BECAUSE OF DISLOCATING. THERE WAS NO LOOSENING. DOCTORS REMOVED THE ORIGINAL IMPLANTS AND CHANGED THE OFFSET OF THE STEM FROM A STANDARD TO A HIGH. AFTER TRIALING PATIENT FELT THAT THE HIP WAS STABLE. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24152962 ↗MalfunctionDec 9, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WAS A BATCH DIFFERENCE BETWEEN DATAMATRIX LABEL AND LABEL ON BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23759823 ↗MalfunctionOct 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PLASTIC PORTION OF THE BIPOLAR WAS TOGGLING INSIDE THE METAL BIPOLAR AND THE SURGEON WAS NOT COMFORTABLE IMPLANTING IT. AN EXTRA 45MM BIPOLAR HEAD WAS AVAILABLE, THEREFORE, NO SURGICAL DELAY AND NO ADVERSE EFFECTS NOTED. DOI: (B)(6) 2025, DOE: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23342593 ↗MalfunctionOct 15, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THE CUSTOMER REPORTS 3 INCIDENTS FOR THE CASE BELOW: DEFECTIVE CUP IN FAILURE OF PLACEMENT (IMD). DURING AN INTERMEDIATE HIP PROSTHESIS, THE DEFINITIVE ACETABULAR IMPLANT DOES NOT CLIP CORRECTLY; THE SURGEON REQUESTS ANOTHER IMPLANT. NO SIGNIFICANT SLOWDOWN ON THE DURATION OF SURGERY, LESS THAN 5 MINUTES. THE COMPLAINT: (B)(4) ARE LINKED.
Patient problems: Insufficient Information
MAUDE report 23303962 ↗MalfunctionOct 15, 2025Difficult to Insert; Difficult to Insert
T WAS REPORTED THE CUSTOMER REPORTS 3 INCIDENTS FOR THE CASE BELOW: DEFECTIVE CUP IN FAILURE OF PLACEMENT (IMD). DURING AN INTERMEDIATE HIP PROSTHESIS, THE DEFINITIVE ACETABULAR IMPLANT DOES NOT CLIP CORRECTLY; THE SURGEON REQUESTS ANOTHER IMPLANT. NO SIGNIFICANT SLOWDOWN ON THE DURATION OF SURGERY, LESS THAN 5 MINUTES. THE COMPLAINT: (B)(4) ARE LINKED.
Patient problems: Insufficient Information
MAUDE report 23302986 ↗MalfunctionOct 15, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED ON (B)(6) 2025, THERE WAS A DEFECTIVE CUP IN FAILURE OF PLACEMENT (IMD). DURING AN INTERMEDIATE RIGHT HIP PROSTHESIS, THE DEFINITIVE ACETABULAR IMPLANT DOES NOT CLIP CORRECTLY; THE SURGEON REQUESTS ANOTHER IMPLANT. NO SIGNIFICANT SLOWDOWN ON THE DURATION OF SURGERY, LESS THAN 5 MINUTES.
Patient problems: Insufficient Information
MAUDE report 23300708 ↗MalfunctionSep 16, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE BI-POLAR HEAD IMPLANT DID NOT WORK PROPERLY. AFFECTED SITE - RIGHT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23065029 ↗MalfunctionAug 7, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE LINER WOULD NOT FIT THE BIPOLAR SHELL, IT WAS TOO LOOSE AND WOULD NOT SEAT IN THE COMPONENT. AFFECTED SIDE: UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22736692 ↗InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS INFECTED. THE SURGEON DID HEAD BALL EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 22689612 ↗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 22634871 ↗InjuryJul 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD A PRIOR HEMIARTHROPLASTY DONE ON (B)(6) 2025. THE PATIENT CAME BACK TO THE EMERGENCY ROOM FOR A HIP DISLOCATION. THE PATIENT WAS BROUGHT TO THE OR AND UNDERWENT REMOVAL OF THE STEM, BIPOLAR HEAD AND 28 HEAD BALL AND THEY WERE REPLACED WITH A LARGER CEMENTED STEM AND NEW BIPOLAR HEAD AND 28 HEAD BALL. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 22461111 ↗InjuryMay 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED HIP MULTIPLE TIMES. PATIENT HAD CLOSED REDUCTIONS. PATIENT CONVERTED TO TOTAL HIP FROM HEMI. AFFECTED SIDE: UNKNOWN.
Patient problems: Fall; Joint Dislocation
MAUDE report 22034792 ↗InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD COMPLAINTS OF LEG BEING SHORT AFTER BIPOLAR FOR HIP FRACTURE. CUP WAS IMPLANTED WITH A LONGER HEAD. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Physical Asymmetry
MAUDE report 21930877 ↗InjuryMar 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION OF A BIPOLAR CONSTRUCT. SURGEON PERFORMED CONVERSION TO A TOTAL HIP. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 21726731 ↗MalfunctionMar 14, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED WHEN THE HEAD WAS INSERTED INTO THE INNER COMPONENT OF THE POLYETHYLENE CUP, THE ASSEMBLY DID NOT ARTICULATE SMOOTHLY CREATING A RESISTANCE. THE POLYETHYLENE PART ALSO LEAKED OUT OF THE CUP.
Patient problems: Insufficient Information
MAUDE report 21605426 ↗InjuryNov 12, 2024Adverse 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 PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 20663134 ↗MalfunctionOct 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE BIPOLAR CUP IMPLANT HAD A LOOSE LINER. PRODUCT WAS UNABLE TO BE USED PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20469757 ↗InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO HIP WAS INFECTED. SURGEON DID AN IRRIGATION AND DEBRIDEMENT AND A HEAD EXCHANGE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 20407952 ↗InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS A RIGHT HEMI HIP DONE BY SURGEON. THE HIP IS PAINFUL AND NEEDS TO BE CONVERTED TO A TOTAL HIP. THE SURGEON REMOVED THE BIPOLAR HEAD AND IMPLANTED A ACETABULAR CUP AND LINER. THE STEM WAS WELL FIXED AND RETAINED. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 20267636 ↗InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, THAT THE ITEMS WERE REMOVED, DUE TO INFECTION OF PATIENT. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 19468027 ↗InjuryMay 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT BIPOLAR DISASSOCIATED WHEN ER WAS TRYING TO REDUCE DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 19221820 ↗
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
- 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
- Compress® Device 178552Biomet Orthopedics, LLC · 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.