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SIGMA 1960-20-400Recalls & reported problems

Depuy (Ireland) · SIGMA FEMORAL CR150 CEMENTED SIZE 4 LEFT · Class 3 · Implant

All models of SIGMA (380)

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

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295074878), received between Jan 9, 2018 and May 23, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Adverse Event Without Identified Device or Use Problem3
  • Insufficient Device Problem Information1
  • Loss of or Failure to Bond1
  • Noise, Audible1
  • Patient Device Interaction Problem1

Patient problems

  • Joint Laxity2
  • Pain2
  • Unspecified Infection2
  • Foreign Body Reaction1
  • No Code Available1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION COMPLETED DUE TO PAIN. ALL IMPLANTS WERE REMOVED AND REVISION WAS DONE WITH ATTUNE REVISION. IMPLANTS WERE ALL WELL FIXATED.

    Patient problems: Pain

    MAUDE report 14471541 ↗
  • InjuryApr 7, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

    REVISION COMPLETED DUE TO INFECTION OF KNEE JOINT AND LOOSE FEMUR. DOI: (B)(6) 2013. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 14046254 ↗
  • InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CR150 LEFT KNEE REPLACEMENT REQUIRES REVISION DUE TO INSTABILITY IN BOTH FLEXION AND EXTENSION. PRIMARY PROCEDURE DATE: (B)(6) 2019.

    Patient problems: Joint Laxity

    MAUDE report 10889349 ↗
  • InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 9219413 ↗
  • InjuryOct 5, 2018Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

    REVISION DUE TO PAIN, INSTABILITY, AND CLUNK. DOI: (B)(6) 2012; DOR: (B)(6) 2013; (LEFT KNEE).

    Patient problems: Joint Laxity; Pain

    MAUDE report 7938875 ↗
  • InjuryJan 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PATIENT WAS REVISED TO ADDRESS ALLERGY TO NICKEL AND LOOSENING OF UNKNOWN COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2010. DOR: (B)(6) 2017. LEFT KNEE.

    Patient problems: Foreign Body Reaction

    MAUDE report 7174862 ↗

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

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Sources and updates

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