P.F.C. SIGMA 96-2024Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295240709), received between Dec 7, 2018 and May 11, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2021Naturally Worn; Naturally Worn

  ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS TIBIAL INSERT POLYETHYLENE WEAR, PAIN, INSTABILITY, AND SYNOVITIS. THE TIBIAL INSERT WAS THE ONLY PRODUCT REVISED. THE SURGEON NOTED DURING PREPARATION OF THE KNEE FOR THE NEW COMPONENT THERE WAS A PARTIAL AVULSION OF THE PATELLA TENDON FROM THE KNEE TIBIAL TUBERCLE. THIS AREA WAS OVER SEWN WITH TWO SUTURES.

  Patient problems: Insufficient Information; Joint Laxity; Pain; Synovitis

  MAUDE report 11807141 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO A POSTERIOR STABILIZED FEMUR AND PS RP POLY DUE TO A LAX PCL LIGAMENT AND INSTABILITY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9711908 ↗
• InjuryDec 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. SURGEON ELECTED TO DO AN EXPLORATORY REVISION. SURGEON REMOVED ARTHROFIBROSIS TISSUE AND EXCHANGED THE INSERT. DOI: (B)(6) 2013. DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Fibrosis; No Code Available; Pain

  MAUDE report 8141674 ↗