P.F.C. SIGMA 96-2136Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295241294), received between Jul 23, 2020 and Jul 6, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT A PRIMARY BILATERAL KNEE ARTHROPLASTY TO ADDRESS SEVERE DEGENERATIVE GONARTHROSIS AND CHONDROMALACIA. THE PATELLA WAS RESURFACED AND DEPUY PRODUCTS WERE IMPLANTED WITH DEPUY CEMENT X 1 FOR EACH KNEE. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS PAIN AND TIBIAL TRAY SUBSIDENCE. THE SURGEON NOTED REMOVAL OF SCAR TISSUE. THE TIBIAL TRAY TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2012, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 12125942 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS INFECTION. REMOVED IMPLANTS AND PLACED NEW IMPLANTS. LOOSENING IS UNKNOWN AND NO DELAY IN SURGERY REPORTED. UNKNOWN CEMENT MANUFACTURER. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11786212 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP WAS PERFORMED DUE TO INSTABILITY AND REMOVAL OF CLUNKING LCS METAL BACKED PATELLA. DOI: (B)(6) 2017, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10315450 ↗