SIGMA 97-0420Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295250371), received between Dec 13, 2022 and Dec 13, 2022 — 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

Recent adverse event reports

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

• MalfunctionDec 13, 2022Difficult to Insert; Difficult to Insert

  ONE OF OUR CUSTOMERS, WHO USED SIGMA TIBIAL TRAY IN COCR VERSION SO FAR, FOR ECONOMIC REASONS HAD TO SWITCH TO A CHEAPER SOLUTION AND THAT IS FB MODULAR TITANIUM TRAY. AFTER THIS CHANGE HE CLAIMS THAT ONE TYPE OF INSERT DOES NOT FIT HIM IN THE TITANIUM TRAY AS WELL AS IN THE COCR TRAY - THIS IS THE SIGMA FB CURVED PLUS INSERT. CUSTOMER ASKING FOR CONFIRMATION OF THE COMPATIBILITY OF THE TWO ELEMENTS, I.E. SIGMA FB MODULAR TITANIUM TIBIAL TRAY (866022 ¿ 866029) IN COMBINATION WITH SIGMA FB CURVED PLUS INSERT (970420 ¿ 970485).

  Patient problems: Insufficient Information

  MAUDE report 15969093 ↗