P.F.C. SIGMA 1581-21-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295064039), received between Nov 1, 2021 and Aug 17, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD THEIR KNEE DONE AROUND 2002. THE SURGEON WASN¿T SURE OF THE EXACT DATE THE PROCEDURE WAS DONE. THE PATIENT WAS FEELING SOME INSTABILITY IN THEIR KNEE, SO THE SURGEON FELT THEY WOULD BENEFIT FROM A POLY EXCHANGE. A SIZE 2, 15MM STABILIZED INSERT WAS REMOVED. I WAS UNABLE TO READ ANY LOT NUMBERS FROM THE UNDERSIDE OF THE POLY AS THEY HAD WORN OFF. A TRIAL REDUCTION WAS PERFORMED WITH A 17.5MM INSERT AND FOUND TO BE STABLE. THE REAL IMPLANT WAS OPENED AND INSERTED. THE KNEE WAS RUN THROUGH A FULL RANGE OF MOTION AND STABILITY WAS CONFIRMED. THE CLOSING PROCESS BEGAN. DOI: 2002; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15240401 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH FLEXION LAXITY- POLY SWAPPED TO A STAB PLUS INSERT. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12727520 ↗