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SIGMA 1024-53-511Recalls & reported problems

Depuy (Ireland) · SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 5 LM/RL 11mm XLK · Class 2 · Implant

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 10603295002673), received between Oct 13, 2020 and Oct 13, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Damaged Prior to Use1
  • Difficult to Insert1

Patient problems

  • No Code Available1
  • Not Applicable1

Recent adverse event reports

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

  • MalfunctionOct 13, 2020Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

    IT WAS REPORTED THAT SIGMA HP POLY WOULD NOT ENGAGE IN THE TIBIAL TRAY. SEEMS TO HAVE A DEFORMED LIP ON THE INSERT THERE WAS A SURGICAL DELAY OF 10 MINUTES.

    Patient problems: No Code Available; Not Applicable

    MAUDE report 10672145 ↗

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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.