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P.F.C. SIGMA 96-2125Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED 2.5 (STAB) 20mm 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 10603295241218), received between Feb 1, 2018 and Feb 1, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

  • Insufficient Device Problem Information1

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.

  • InjuryFeb 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PATIENT WAS REVISED TO ADDRESS ACTIVE INFECTION. KNEE WASHED OUT AND POLY EXCHANGE WAS DONE. DOI: 1-2 MONTHS; DOR: (B)(6) 2018; LEFT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 7234444 ↗

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Sources and updates

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