P.F.C. SIGMA 1581-21-117Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295064046), received between Oct 10, 2017 and Mar 30, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS GROSS INSTABILITY AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. DATE OF ORIGINAL SURGERY IS UNKNOWN. WITH A SURGICAL DELAY OF UNKNOWN MINUTES. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11590004 ↗
• InjuryOct 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES POLY SWAP DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6936802 ↗