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P.F.C. SIGMA 96-0831Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA DISTAL AUGMENT COMBO SIZE 2 16mm LEFT · 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 10603295234142), received between Oct 29, 2021 and Oct 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.

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

    THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO LOOSENING REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 12719458 ↗

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Sources and updates

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