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SIGMA 1960-30-500Recalls & reported problems

Depuy (Ireland) · SIGMA FEMORAL CR150 CEMENTED SIZE 5 RIGHT · Class 3 · Implant

All models of SIGMA (380)

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

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295074984), received between Sep 11, 2020 and Jan 22, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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

  • Loss of or Failure to Bond2

Patient problems

  • Insufficient Information1
  • No Code Available1

Recent adverse event reports

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

  • InjuryJan 22, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

    ASEPTIC LOOSENING ON A PROSTHESIS IMPLANT.

    Patient problems: Insufficient Information

    MAUDE report 11216356 ↗
  • InjurySep 11, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

    PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2013, DOR: (B)(6) 2020 RIGHT KNEE.

    Patient problems: No Code Available

    MAUDE report 10523727 ↗

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Sources and updates

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