SIGMA 1024-54-508Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295002949), received between Nov 29, 2018 and Dec 16, 2021 — classified as 1 injury, 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

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

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT KNEE MEDIAL SIDE RM.

  Patient problems: Insufficient Information

  MAUDE report 13017606 ↗
• InjuryJun 12, 2020Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  PROCEDURE: SIGMA PARTIAL KNEE REPLACEMENT. I WAS PRESENT AT THE ORIGINAL CASE WHICH WAS DONE ON 28/05. WHEN WE WERE ABOUT TO IMPLANT THE DEFINITIVE TIBIAL INSERT (7MM) THE SCRUB NURSE ACCIDENTALLY THREW IT IN THE RUBBISH BIN. WE ONLY HAD ONE SET OF IMPLANTS ON SITE, SO WE HAD NO OPTION BUT TO PUT THE 8MM IN AND THEN CLOSE THE WOUND. I SPOKE TO THE SURGEON AFTER THE CASE AND HE SAID THAT THE KNEE WAS PREPARED AND BALANCED FOR A 7MM AND THE 8MM WAS TOO TIGHT, AND THAT HE WOULD NEED TO SWAP THE TIBIAL INSERT OUT TOMORROW.

  Patient problems: No Code Available

  MAUDE report 10146926 ↗
• MalfunctionNov 29, 2018Fitting Problem; Fitting Problem

  ONCE IMPLANTED THE TIBIAL COMPONENT, THE SURGEON TRIED TO PLACE TO INSERT BUT BOTH DIDN'T ASSEMBLY TO THE TIBIAL COMPONENT. THE TIBIAL COMPONENT WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116355 ↗