Skip to content

SIGMA 1024-55-508Recalls & reported problems

Depuy (Ireland) · SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 5 LM/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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295501664), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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

  • Difficult to Insert1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 16, 2021Difficult to Insert; Difficult to Insert

    IT WAS REPORTED THAT THE POLY IS UNSTABLE AFTER LOCKED INTO TRAY. WAS PISTONING ¿ PLEASE CHECK SPECS AND GET BACK TO DOC.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12820782 ↗

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

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

Sources and updates

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