P.F.C. SIGMA 96-2061Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295241003), received between Aug 18, 2017 and May 16, 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.

• InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE CEMENT MANUFACTURER WAS NOT INDICATED. NO REPORTED LOOSENING. UNKNOWN IF ANY SURGICAL DELAY. DOI: (B)(6) 2013; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 14407658 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND SWELLING. KNEE WAS INFECTED AND REMOVED IMPLANTS. INSERTED ANTIBIOTIC SPACER WAS DONE. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2016 (FEMORAL, PATELLA AND TIBIAL TRAY), (B)(6) 2019 (TIBIAL INSERT). DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema

  MAUDE report 12438784 ↗
• InjurySep 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PERSISTENT PAIN. IT WAS ALSO REPORTED THAT AN OBSTRUCTION IN THE BACK KNEE SPACE POSTERIORLY FOUND A LARGE BONY OSTEOPHYTE. IT WAS REMOVED WITH POLY EXCHANGE.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 6861754 ↗
• InjuryAug 18, 2017Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS POLY WEAR, INFECTION WASN'T CONFIRMED. THERE WAS NO LOOSENING OF THE TIBIAL INSERT (PER FOLLOW UP) AND BASED OFF THE FOLLOW-UP AND IMPLANT PICTURES IT LOOKS LIKE IT WAS JUST POLY WEAR.

  Patient problems: No Information

  MAUDE report 6804677 ↗