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P.F.C. SIGMA 96-1700Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA FLUTED FEMORAL STEM 12mm x 125mm 7 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 10603295239901), received between Sep 21, 2020 and Sep 21, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated1

Patient problems

  • Bone Fracture(s)1
  • No Code Available1

Recent adverse event reports

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

  • InjurySep 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REASON FOR SURGERY WAS THE SINKING OF THE TIBIAL SIDE AND THEN OCCURRING THE FRACTURE. BONE FRACTURE WAS CONFIRMED.

    Patient problems: Bone Fracture(s); No Code Available

    MAUDE report 10562306 ↗

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Sources and updates

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