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P.F.C. SIGMA 96-2127Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED 2.5 (STAB) 25mm GVF · 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 10603295241232), received between Oct 21, 2019 and Oct 21, 2019 — 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

  • No Code Available1
  • Pain1

Recent adverse event reports

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

  • InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS REVISED DUE TO PAINFUL RIGHT KNEE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

    Patient problems: No Code Available; Pain

    MAUDE report 9214914 ↗

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Sources and updates

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