P.F.C. SIGMA 1581-22-117Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295064206), received between Jul 31, 2017 and Feb 4, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. SURGEON DISTALIZED THE PATIENT'S FEMORAL COMPONENT AND REVISED THE FEMORAL & INSERT. DOI: (B)(6) 2021. DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13450314 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY WAS REMOVED, KNEE WAS WASHED OUT AND NEW POLY OF DAMES SIZE WAS RE-IMPLANTED. LOT NUMBER WAS UNAVAILABLE FOR IMPLANT THAT WAS REMOVED. NO OTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY. DOI: (B)(6) 2007. DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 11495469 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY ISSUES. A REVISION KNEE WAS REPLACED. ORIGINAL IMPLANT DATE AND LOT NUMBERS ON IMPLANTS THAT WERE REMOVED ARE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10852045 ↗
• InjuryJul 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS SEPSIS.

  Patient problems: Unspecified Infection

  MAUDE report 6753494 ↗