P.F.C. SIGMA 1581-23-117Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295064367), received between Oct 18, 2018 and Nov 22, 2022 — classified as 4 injuries.

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.

• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH WASHOUT OF POLY EXCHANGE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15842989 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SAID THE PATIENT WAS SUFFERING FROM A DEVELOPMENTAL FLEXION CONTRACTURE. HE NEEDED TO OPEN UP THE KNEE AND DO SOME RELEASES AND DEBRIDEMENT OF SCAR TISSUE. ONCE HE CLEARED OUT THE KNEE, HE TRAILED WITH A SZ 3 8MM PS INSERT. HE WAS ABLE TO IMPROVE THE RANGE OF MOTION GREATLY. THE SZ 3 8MM PS INSERT WAS OPENED AND IMPLANTED. THERE WAS A POLY EXCHANGE BACK IN SEPTEMBER OF 2017, THE REASON FOR THE REVISION WAS NOT KNOWN. ORIGINAL IMPLANT DATE WAS UNKNOWN AS WELL. DOI: (B)(6) 2017, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 10482573 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS STIFF KNEE.SURGEON PERFORMED AN IRRIGATION AND DEBRIEDMENT AND INSERTED A STABILIZED PLUS INSERT OF THE SAME THICKNESS. NO SURGICAL DELAY. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2013; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9386259 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED PAIN AND WAS BROUGHT TO THE OR FOR A POLYETHELENE LINER EXCHANGE.

  Patient problems: No Code Available; Pain

  MAUDE report 7977206 ↗