P.F.C. SIGMA 95-1060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295230496), received between Jan 10, 2022 and Dec 12, 2025 — 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.

• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POLY SWAP AND A REVISION KNEE SURGERY DUE TO JOINT INSTABILITY AND PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23794396 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR OCCLUSIVE THROMBUS IN MEDIAL GASTRONCNEMIUS VEIN EXTENDING FROM 90MM BELOW THE KNEE CREASE TO 10MM ABOVE THE KNEE CREASE : VASCULAR - DVT. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015, DATE OF EVENT (ONSET): (B)(6) 2016, (RIGHT KNEE). TREATMENT: ARTHROSCOPY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13289574 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFF LEFT KNEE POST LEFT TOTAL KNEE REPLACEMENT : ADHESIONS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015, DATE OF EVENT (ONSET): (B)(6) 2015, (LEFT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 13288452 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CONTINUED PAIN POST RIGHT TOTAL KNEE REPLACEMENT : SYNOVITIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015, DATE OF EVENT (ONSET): (B)(6) 2016, (RIGHT KNEE). TREATMENT: ARTHROSCOPY.

  Patient problems: Pain; Synovitis

  MAUDE report 13205732 ↗