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SIGMA 1024-53-308Recalls & reported problems

Depuy (Ireland) · SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 3 LM/RL 8mm XLK · Class 2 · Implant

All models of SIGMA (380)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295002543), received between Jun 5, 2019 and Feb 1, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 16, 2026.

Most reported problems

Device problems

  • Difficult to Insert3
  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Not Applicable2
  • Joint Laxity1
  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • Unspecified Infection1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 1, 2021Difficult to Insert; Difficult to Insert

    TROUBLE SEATING A SIGMA PARTIAL INSERT. NO PATIENT HARMS OR SURGICAL DELAYS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11259333 ↗
  • InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE KNEE WAS UNSTABLE, THICKER POLY ACHIEVED STABILITY. DOI: (B)(6) 2014. DOR: (B)(6) 2020; RIGHT KNEE.

    Patient problems: Joint Laxity

    MAUDE report 10884692 ↗
  • MalfunctionSep 25, 2019Difficult to Insert; Difficult to Insert

    IT WAS REPORTED THAT THE FINAL POLY WOULD NOT ALIGN ON BOTH SIDES OF TRAY TO BE SNAPPED INTO PLACE. TRIED FOR 90 MINUTES TO NO AVAIL. SURGEON REMOVED WELL FIXED METAL BACK TIBIA AND CEMENTED IN ALL POLY.

    Patient problems: Not Applicable

    MAUDE report 9119073 ↗
  • MalfunctionSep 25, 2019Difficult to Insert; Difficult to Insert

    IT WAS REPORTED THAT THE FINAL POLY WOULD NOT ALIGN ON BOTH SIDES OF TRAY TO BE SNAPPED INTO PLACE. TRIED FOR 90 MINUTES TO NO AVAIL. SURGEON REMOVED WELL FIXED METAL BACK TIBIA AND CEMENTED IN ALL POLY.

    Patient problems: Not Applicable

    MAUDE report 9119071 ↗
  • InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS REVISED TO ADDRESS INFECTION. POLY EXCHANGE WAS DONE. DOI: (B)(6) 2019. DOR: (B)(6) 2019; RIGHT KNEE.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 8670235 ↗

Other PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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