P.F.C. SIGMA 96-0500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295232889), received between Jan 21, 2019 and Jan 21, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Disintegration” (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.

• InjuryJan 21, 2019Material Disintegration; Adverse Event Without Identified Device or Use Problem; Material Disintegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONCE THE REVISION SURGERY WAS COMPLETED. HOWEVER, REINFECTION OCCURRED THUS THE 2ND REVISION SURGERY WAS PERFORMED BY WASHING OUT THE DEBRIS AND REPLACING THE LINER (P/N: (B)(4) ON THE PATIENT¿S LEFT KNEE JOINT. IT WAS CONFIRMED THAT THE SURFACE OF THE POLYETHYLENE AT THE POSTERIOR OF THE INSERT WAS TURNED UP. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8264970 ↗