P.F.C. SIGMA 96-0132Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295232803), received between Sep 20, 2018 and Sep 20, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (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 18, 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.

• InjurySep 20, 2018Naturally Worn; Naturally Worn

  PT HAD INSERT AND PATELLA LEFT KNEE REVISED FOR POLY WEAR. ORIGINAL DOS 20 YEARS AGO. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION:PATIENT NEEDED REVISION SURGERY FOR EXCESSIVE POLY WEAR. ACTION TAKEN FOR PROCEDURE:INSERT POLY EXCHANGE AND REVISED PATELLA COMPONENT. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Not Applicable

  MAUDE report 7896634 ↗