P.F.C. SIGMA 95-1051Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295230465), received between Feb 5, 2021 and May 15, 2023 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN IF THERE WAS ANY LOOSENING OF FEMUR OR TIBIA AT CEMENT TO IMPLANT INTERFACE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2007. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16930028 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED LEFT TOTAL KNEE REPLACEMENT AFTER WOUND BREAKDOWN ON (B)(6) 2016 : INFECTION - DEEP. EVENT IS SERIOUS AND IS CONSIDERED SEVERE . EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016; DATE OF EVENT (ONSET): (B)(6) 2016 (LEFT KNEE). TREATMENT: REVISION ON (B)(6) 2016, OF ALL IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 13288869 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INFECTION, POLY INSERT EXCHANGED AS PART OF WASHOUT.

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

  MAUDE report 11870194 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. INSERT EXCHANGE WAS PERFORMED. NO SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2008, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11594717 ↗
• InjuryFeb 5, 2021Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACES. DEPUY CEMENT WAS USED. NO ADDITIONAL INFORMATION. THERE WAS LOOSENING AND SIGNIFICANT DELAMINATION OF THE PATELLA AND SOME ON THE TIBIAL INSERT. THE PATELLA WASN'T LOOSE, BUT THERE WAS LOOSENING ON THE TIBIAL TRAY AND FEMORAL COMPONENT. DOI: (B)(6) 2007, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11285687 ↗