P.F.C. SIGMA 1581-15-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295063636), received between Jan 19, 2018 and Mar 11, 2022 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO LOOSENING. THE PATIENT CAME TO THE ER WITH A SWOLLEN AND PAINFUL RIGHT KNEE. THE KNEE WAS ASPIRATED WHERE IT WAS DETERMINED THE PATIENT HAS A JOINT INFECTION. SURGEON PERFORMED I&D AND EXCHANGED THE POLYETHYLENE INSERT. THE FEMORAL, TIBIAL, AND PATELLA COMPONENTS REMAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13736614 ↗
• InjuryApr 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION IMPLANTS REMOVED AND INSERTED AS A SPACER/ PROSTALAC. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9957715 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RECURRENT HEMARTHROSIS EVENT IS NOT SERIOUS AND IS CONSIDERED MILD EVENT IS POSSIBLY RELATED TO DEVICE AND TO PROCEDURE. DOI: (B)(6) 2012; DOE: (B)(6) 2019; (RIGHT KNEE).

  Patient problems: Edema; Joint Disorder; No Code Available; Pain

  MAUDE report 9564955 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM AN ACUTE INFECTION. SURGEON DID AN I&D AND EXCHANGED THE POLY. DOI: UNKNOWN. DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8977361 ↗
• InjuryJan 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2017. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7205100 ↗