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P.F.C. SIGMA 96-0701Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA FLUTED FEMORAL STEM 14mm x 125mm 5 DEGREE · Class 3 · Implant

All models of P.F.C. SIGMA (487)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295233626), received between Nov 29, 2021 and Nov 29, 2021 — classified as 1 injury.

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 Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE PRIMARY SURGERY. THIS PC REPORTS ABOUT THE REMOVAL SURGERY DUE TO INFECTION. AFTER THE REVISION TKA SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL SURGERY ON (B)(6) 2021 BECAUSE INFECTION OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Unspecified Infection

    MAUDE report 12882802 ↗

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Sources and updates

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