P.F.C. SIGMA 95-1042Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295230434), received between May 6, 2021 and Sep 26, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BECAME UNSTABLE OVER TIME AND REQUIRED A POLY EXCHANGE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20311231 ↗
• InjuryOct 27, 2022Fracture; Fracture

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. GS POLY WAS ALSO DAMAGED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15680765 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED DUE TO INFECTION. POLY SWAP WAS DONE. DOI: (B)(6) 2011, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11782987 ↗