P.F.C. SIGMA 1581-11-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295063148), received between Dec 1, 2017 and Jul 30, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASHED OUT DUE TO INFECTED KNEE AND CHANGED THE LINER. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17421682 ↗
• InjuryMay 20, 2022Naturally Worn; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY AND TIBIA INSERT AND PATELLA POLYWEAR. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2010. DATE OF REVISION: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION OF THE TIBIAL INSERT AND PATELLA.

  Patient problems: Joint Laxity

  MAUDE report 14461247 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO UNSTABLE KNEE. SURGEON EXPLANTED CR POLY REVISING WITH THICKER CVD+ INSERT. DOI: UNKNOWN; DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available

  MAUDE report 9179806 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO LYSIS AROUND THE JOINT. PATELLA IMPLANT WAS LOOSE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8603188 ↗
• InjuryJun 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND DISCOMFORT. SURGEON CLEANED UP THE JOINT SPACE AND PUT IN A POLY INSERT. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Discomfort; Not Applicable; Pain

  MAUDE report 7590965 ↗
• InjuryJun 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  TKR: SURGEON, (B)(6), (B)(6) 2018. PRIMARY IMPLANT (B)(6) 2017. PATIENT HAD A ROUTINE TKR AND HAS COMPLAINED OF PAIN POST OP WITH EVIDENCE OF LOOSENING, INSTABILITY AND THE KNEE IS WELL ALIGNED. KNEE WAS REVISED AND ALL COMPONENT WERE REMOVED. THERE WAS NO EVIDENCE OF LOOSENING OR INSTABILITY. THERE WAS EVIDENCE OF CHRONIC INFLAMMATION. THE KNEE COMPONENTS WERE REMOVED AND EXTENSIVE DEBRIDEMENT WAS PERFORMED. INFECTION IS QUERIED AS A LIKELY CAUSE AND A ONE STAGE REVISION TO A CEMENTED FEMUR AND CEMENTED ALL POLY TIBIA WAS PERFORMED. FEMALE PATIENT INITIALS (B)(6), AGED (B)(6) YEARS, DOB: (B)(6) 1945, WEIGHT: (B)(6).

  Patient problems: Inflammation; Not Applicable; Pain; Unspecified Infection

  MAUDE report 7587525 ↗
• MalfunctionDec 1, 2017Fitting Problem; Fitting Problem

  DER STATES THAT THE PRODUCT WOULD NOT SEAT PROPERLY SO IT WAS REMOVED AND A NEW INSERT OF THE SAME TYPE WAS INSERTED IN THE NORMAL FASHION AND THE SURGEON WAS HAPPY WITH IT. SURGEON THOUGHT IT WAS OUT OF SPEC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7074238 ↗