P.F.C. 85-3834Recalls & reported problems
Depuy International Ltd · P.F.C. Total Hip System FEMORAL HEAD Diameter 28mm +5 10/12 TAPER · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295207610), received between Aug 15, 2017 and May 5, 2021 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Device Dislodged or Dislocated4
Patient problems
- Joint Dislocation4
- No Code Available4
- Pain3
- Joint Laxity1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT RECURRENT DISLOCATOR. ORIGINAL SURGERY 2000. PFC ULTIMA CEMENT STEM SZ 3M AND COMPETITOR CUP. HEAD AND LINER REVISED IN 2020 FOR WEAR AND STABILITY. CURRENT SURGERY, CONSTRAINED LINER CEMENTED INTO AND HEAD REPLACED. DOI: (B)(6) 2020. DOR: (B)(6) 2021; UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 11776805 ↗InjuryFeb 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATIONS WITH INDICATION OF POLY LINER WEAR. NO SURGICAL DELAY. DOI: (B)(6) 1998, DOR: (B)(6) 2021, LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 11367213 ↗InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT STABILITY AND PAIN DUE LINER WEAR. CUP AND LINER ARE COMPETITOR PRODUCTS. DOI: (B)(6) 2000; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity; Pain
MAUDE report 10889647 ↗InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURGEON DID A LEFT HIP REVISION ON (B)(6) 2020, AT (B)(6) DUE TO INSTABILITY. THE PATIENT HAD ORIGINAL SURGERY AROUND 20 YEARS AGO AT (B)(6). THE PATIENT HAD A PINNACLE 56 CUP WITH A PFC 3M STEM AND A 28MM +5 PFC HEAD, +4 10 DEG 28ID LINER. THE 28 PFC HEAD PLUS 5 WAS REMOVED-AND THE LINER WAS REMOVED AND REPLACED WITH DEPUY PARTS. NO FURTHER INFO IS KNOWN OR AVAILABLE AT THIS TIME. TO ANSWER THE QUESTION BELOW-NOTHING WAS BROKEN IN SURGERY AND THEREFORE NO INSTRUMENTATION WAS REMOVED FROM THE PATIENT. DOI: 20 YEARS AGO, DOR: (B)(6) 2020, LEFT HIP.
Patient problems: No Code Available
MAUDE report 10615321 ↗InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO POLY WEAR AND PAIN. NO FURTHER DETAILS. CUP AND STEM WELL FIXED. DOI: (B)(6) 1998; DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.
Patient problems: No Code Available; Pain
MAUDE report 10363105 ↗InjuryJul 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAS HIP REVISION FOR DISLOCATION. DOI: (B)(6) 1999, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 10224351 ↗InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT HIP. THE CUP IS NOT DEPUY SYNTHES. DOI: (B)(6) YEARS OLD. DOR: (B)(6) 2019; LEFT HIP.
Patient problems: No Code Available; Pain
MAUDE report 8342757 ↗InjuryAug 15, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE CLINICAL DER STATES THAT FAILED CONSTRAINED LINER OCCURRED ON (B)(6) 2017 AND THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS ALSO REPORTED THAT DEPUY HEAD WAS REVISED AND IT SHOULD BE NOTED THAT AT TIME OF REVISION ONLY THE STEM AND HEAD WERE DEPUY PRODUCTS, ALL OTHERS WERE COMPETITOR PRODUCTS.
Patient problems: Joint Dislocation
MAUDE report 6793913 ↗
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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