P.F.C. SIGMA RPF 95-0014Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295224020), received between Oct 19, 2017 and Sep 30, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2010, the patient underwent a TKA with the product in question. The surgery was completed successfully without any delay.After the surgery on (b)(6) 2026, the hospital ordered replacement for a debridement and insert replacement following an infection. Upon checking with the logistics department, it was found that there was virtually no stock of RPF inserts remaining; as replacement with a new unit was not possible, the surgeon decided to thoroughly clean and reuse the existing insert. The surgery was completed successfully without any delay.Affected Side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50945009 ↗
• InjuryFeb 5, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT A PFC SIG RPF CEM FEM SZ 3 LT, UNKNOWN KNEE TIBIAL TRAY, UNKNOWN KNEE TIBIAL INSERT, AND UNKNOWN KNEE PATELLA WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED REVISION SURGERY OF A KNEE CONSTRUCT, INCLUDING A FEMORAL COMPONENT, TIBIAL TRAY, TIBIAL INSERT, AND PATELLA. THE REVISION WAS NECESSITATED BY LOOSENING ATTRIBUTED TO POLY LYSIS, WITH MEDIAL WEAR OBSERVED ON THE INSERT. BOTH THE FEMUR AND TIBIA WERE FOUND TO BE LOOSE, WHILE THE PATELLA WAS REVISED DUE TO POLYETHYLENE WEAR. ALL COMPONENTS WERE EXPLANTED. THE PATIENT REQUIRED A CORRECTIVE INVASIVE PROCEDURE IN WHICH THE DEVICES WERE REPLACED OR REVISED. THE LOOSENING WAS IDENTIFIED AT THE IMPLANT TO CEMENT INTERFACE, AND WEAR OR DETERIORATION OF POLYETHYLENE MATERIAL WAS NOTED. OSTEOLYSIS WAS ALSO REFERENCED AS A RELATED CONDITION. IMPLANTED IN 2006. EXPLANTED (B)(6) 2026.

  Patient problems: Insufficient Information

  MAUDE report 24267145 ↗
• InjuryJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  LOOSE FEMORAL COMPONENT. PFC PS RP CONSTRUCT. DATE OF IMPLANT NOT KNOWN. IMAGES PROVIDED BY JNJ REPRESENTATIVE UPLOADED TO ECM.

  Patient problems: No Code Available

  MAUDE report 9547319 ↗
• InjurySep 6, 2019Malposition of Device; Malposition of Device

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, INSTABILITY AND FEMORAL COMPONENT MALPOSITIONING. THE SURGEON NOTED THE MEDIAL PORTION OF THE FEMORAL COMPONENT WAS APPROXIMATELY 11 MM ABOVE THE ANTERIOR CORTEX OF THE FEMUR. DOI: (B)(6) 2009; DOR: (B)(6) 2010, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8970019 ↗
• InjuryOct 19, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT KNEE DUE TO MECHANICAL LOOSENING OF THE FEMUR AND TIBIA COMPONENTS AT CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED.

  Patient problems: No Information

  MAUDE report 6961306 ↗