P.F.C. SIGMA RPF 95-0016Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295224044), received between May 10, 2019 and May 15, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).

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 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 16930165 ↗
• InjuryJan 4, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT UNDERWENT LEFT PRIMARY TKR IN 2006. AT THIS TIME A PRIMARY PFC RPF FEMORAL COMPONENT SIZE 5 LEFT AND A CEMENTLESS DUOFIX MBT TRAY WAS UTILISED (CAT NUMBERS AND LOT NUMBERS COULD NOT BE ESTABLISHED). PATIENT HAS DONE WELL FOR A NUMBER OF YEARS (UNDERTAKING MANUAL WORK) AND STARTED TO FEEL PAIN IN THE LAST 2 YEARS. X-RAYS SHOW A LOOSE FEMORAL COMPONENT ALONG WITH WEAR OF THE TIBIAL INSERT ON THE MEDIAL SIDE. ON OPENING THE KNEE THE FEMORAL COMPONENT WAS OBVIOUSLY LOOSE (THIS COMPONENT HAD DEBONDED AT THE IMPLANT CEMENT INTERFACE AND SHOWED SIGNED OF POLISHING WHERE THERE HAD BEEN MOVEMENT BETWEEN THE CEMENT AND THE IMPLANT). GRANULOMAS SOFT TISSUE WAS EXCISED FROM THE EXTENSOR MECHANISM, AND THERE WERE ETEOLYTIC LESIONS IN THE DISTAL FEMORAL BONE. THE DUOFIX TRAY WAS NOT OVERTLY LOOSE BUT DID COME AWAY FROM THE TIBIAL BONE WITHOUT TOO MUCH EFFORT. THE PATELLA COMPONENT WAS LEFT IN SITU. AN ATTUNE REVISION COMPONENT WAS IMPLANTED ALONG WITH BOTH FEMORAL AND TIBIAL SLEEVES. GOOD STABILITY AND FIXATION WERE ACHIEVED.

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

  MAUDE report 11113522 ↗
• InjuryMay 10, 2019Loss of or Failure to Bond; Patient-Device Incompatibility; Loss of or Failure to Bond; Patient-Device Incompatibility

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE SIGMA RPF FEMUR AND INSERT REMOVED DUE TO BEING OVERSIZED AND POSSIBLY LOOSE. THE FEMUR WAS LOOSE WITH NO CONTACT OF AN IMPLANT TO ANTERIOR AND POSTERIOR FACES. THE COMPONENT WAS TOO LARGE FOR THE PATIENT. NO INFECTION PRESENT. RE-IMPLANTED TO TC3 WITH CEMENTED STEM AND TC3 INSERT. MBT REVISION TRAY FROM ORIGINAL SURGERY WAS RETAINED. DOI: (B)(6) 2016; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8601554 ↗