P.F.C. 85-3842Recalls & reported problems
Depuy International Ltd · P.F.C. Total Hip System FEMORAL HEAD Diameter 32mm +5 10/12 TAPER · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295207634), received between May 29, 2020 and Mar 12, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 Dislocated2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Joint Dislocation2
- Fall1
- Joint Laxity1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. NO FURTHER INFORMATION IS PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 21585386 ↗InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SURGEON PERFORMED A HIP REVISON, PRIMARY HIP ARTHROPLASTY WAS PERFORMED IN 2018. PATIENT COMPLAINED OF HIP SLIPPING, SURGEON SUSPECTED THIS WAS DUE TO THE LINER BEING DISASSOCIATED FROM THE CUP. LINER AND CUP WERE EXPLANTED AND REPLACED WITH A TRIDENT CUP. DOI: 2018. DOE: (B)(6) 2024.
Patient problems: Joint Laxity
MAUDE report 19839756 ↗InjuryMay 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAS FALLEN A FEW TIMES AND IS A MULTIPLE DISLOCATOR. PULLING THE LINER AND GOING TO A CONSTRAINED LINER WITH A HEAD EXCHANGE. NO COMPLAINTS OR PROBLEMS WITH OUR IMPLANTS. DOI: (B)(6) 2004; DOR: (B)(6) 2020; LEFT HIP.
Patient problems: Fall; Joint Dislocation; No Code Available
MAUDE report 10102768 ↗
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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