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P.F.C. SIGMA 96-1880Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA DISTAL AUGMENTATION TRIAL SZ 4 4mm · Class 1

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

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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295240372), received between Feb 14, 2018 and Jan 7, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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

  • Break2
  • Fracture1

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 7, 2020Break; Break

    A DISTAL AUGMENT BROKE WHERE IT ATTACHES TO THE TRIAL FEMUR.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9557639 ↗
  • MalfunctionFeb 14, 2018Break; Fracture; Break; Fracture

    UPDATED 16 FEB 2018 RECEIVED NEW DER FOR THE FOLLOW UP REQUEST. AS PER SALES REP FRACTURE MEANING THEY WERE BROKEN INTO TWO PIECES. NO LOT NUMBERS ARE AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7269281 ↗

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Sources and updates

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