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SIGMA 1960-20-300Recalls & reported problems

Depuy (Ireland) · SIGMA FEMORAL CR150 CEMENTED SIZE 3 LEFT · 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 10603295074861), received between Mar 18, 2020 and May 11, 2021 — classified as 2 injuries.

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 Problem2

Patient problems

  • Insufficient Information1
  • No Code Available1
  • Pain1

Recent adverse event reports

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

  • InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    KNEE REVISION ALL HARDWARE WAS REMOVED AND REPLACED.

    Patient problems: Insufficient Information

    MAUDE report 11807772 ↗
  • InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION OF CR150 RP KNEE.

    Patient problems: No Code Available; Pain

    MAUDE report 9851293 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices

All Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices →

Sources and updates

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