P.F.C. SIGMA RPF 95-0022Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295224082), received between Feb 20, 2018 and Aug 7, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement. A DePuy Synthes Implant was revised and reviewed for analysis.Reason for revision: Revision due to pain and stiffness.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 50179895 ↗
• InjuryFeb 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18788769 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PERIPROSTHETIC INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 18248185 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PAINFUL POST-OP. THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTY IN ORDER TO RESTORE JOINT FUNCTION DUE TO OSTEOARTHRITIS OF BOTH KNEES 5 YEARS AGO. JOHNSON & JOHNSON PFC SIGMA RPF TOTAL KNEE SYSTEM WAS USED IN THE SURGERY ON (B)(6) 2014. THE PATIENT'S LEFT KNEE RECOVERED WELL AFTER SURGERY, AND THE RIGHT KNEE FUNCTION RECOVERED UNSATISFACTORILY WITH INSTABILITY AND FELT JOINT PAINFUL DURING WALKING. SHE WAS DIAGNOSED WITH INSTABILITY AFTER RIGHT KNEE ARTHROPLASTY ON (B)(6) 2019 AND UNDERWENT A RIGHT KNEE REVISION PROCEDURE ON (B)(6) 2019. INTRAOPERATIVE OBSERVATIONS WERE CONSISTENT WITH A DIAGNOSIS OF INSTABILITY, AND IT WAS NOT RELATED TO JOINT IMPLANT, IT IS RELATED TO SURGERY OR PATIENT. THE PATIENT'S JOINT FUNCTION RECOVERED AFTER REVISION SURGERY.

  Patient problems: No Code Available; Pain

  MAUDE report 9000706 ↗
• InjuryFeb 20, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PRIMARY SURGERY WAS PERFORMED VIA TKA WITH SIGMA PRF IMPLANTS ON (B)(6) 2007. THE PATIENT COMPLAINED THE PAIN AFTER THE SURGERY. THE SURGEON CONFIRMED THAT THE TIBIAL BONE IMPLANT WAS INCLINED SLIGHTLY FORWARD DUE TO THE BONE MISSING AT BEHIND THE TIBIA UNDER X-RAY. ALSO, FOR THE FEMUR SIDE, THE GAP BETWEEN THE BONE IN THE FRONT FLANGE PORTION WAS OBSERVED, SO THAT THE LOOSENING WAS OCCURRED AT THE IMPLANT. THE REVISIONS SURGERY WAS PERFORMED ON (B)(6) 2018 TO REPLACE ALL IMPLANTS TO ANOTHER MANUFACTURER¿S IMPLANTS EXCEPT FOR SIGMA/OV/DOME (P/N: (B)(4)). THE SURGEON DECIDED TO KEEP SIGMA/OV/DOME IN THE PATIENT¿S KNEE JOINT BECAUSE THERE WAS A POSSIBILITY THAT IT BECOMES TOO THIN IF EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Pain

  MAUDE report 7281882 ↗