Skip to content

SIGMA 1024-54-308Recalls & reported problems

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

All models of SIGMA (380)

Data updated Oct 16, 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 10603295002840), received between Nov 7, 2022 and Nov 7, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (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 16, 2026.

Most reported problems

Device problems

  • Naturally Worn1

Patient problems

  • Muscular Rigidity1
  • Pain1

Recent adverse event reports

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

  • InjuryNov 7, 2022Naturally Worn; Naturally Worn

    REVISION OF 15 YEAR OLD SIGMA PARTIAL COMPLETED DUE TO PAIN AND STIFFNESS. THE INLAY LOOKS FINE. SMALL SCRATCHES WERE FOUND ON THE SURFACE. FEMUR AND TIBIA VERY STABLE AND PERFECTLY INTEGRATED.

    Patient problems: Muscular Rigidity; Pain

    MAUDE report 15749436 ↗

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

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

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page