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SIGMA 1024-55-408Recalls & reported problems

Depuy (Ireland) · SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 4LM/RL 8MM · 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 10603295501619), received between May 4, 2022 and May 4, 2022 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS REVISED FOR INFECTION. REMOVED THE OLD UNI INSERT, WASH THE KNEE OUT APPLIES SOME ANTIBIOTICS. IMPLANTED A NEW SZ 4 LM UNI INSERT. THERE WAS DELAY IN SURGERY. NO INJURY TO PATIENT. THIS IS THE PATIENT'S LEFT KNEE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; LEFT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 14278407 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices

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Sources and updates

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