P.F.C. 85-7724Recalls & reported problems
Depuy International Ltd · P.F.C. TOTAL HIP SYSTEM ACETABULAR LINER 28mm 10 DEGREES 54-58mm · 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 10603295215202), received between Jul 21, 2017 and Apr 22, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Naturally Worn” (3 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
- Naturally Worn3
Patient problems
- No Consequences Or Impact To Patient1
- No Information1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POLY WEAR AND PAIN. DOR: (B)(6) 2021, RIGHT SIDE.
Patient problems: Pain
MAUDE report 11712014 ↗InjuryNov 30, 2017Naturally Worn; Naturally Worn
DER STATES SURGEON SAID THE ONLY REASON FOR REVISION IS POLY WEAR OVER THE MANY YEARS SINCE IMPLANTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7070565 ↗InjuryJul 21, 2017Naturally Worn; Naturally Worn
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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