P.F.C. SIGMA RPF 95-0012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295224006), received between Apr 3, 2020 and May 9, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PRIMARY SURGERY WAS PERFORMED VIA TKA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON AN UNKNOWN DAY IN (B)(6) 2023, THE PATIENT VISITED THE DOCTOR COMPLAINING OF PAIN. NO LOOSENING WAS OBSERVED IN THE X-RAY FINDINGS. ON (B)(6) 2023, LOOSENING OF THE IMPLANTS DUE TO DEBONDING WAS CONFIRMED BY OPEN WOUND. THE IMPLANTS WERE REVISED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 16894577 ↗
• InjurySep 2, 2020Loss of or Failure to Bond; Malposition of Device; Loss of or Failure to Bond; Malposition of Device

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011 VIA TKA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE FEMORAL COMPONENT, THE TIBIAL INSERT AND THE TIBIAL TRAY DUE TO LOOSENING OF THE IMPLANTS. THE FEMORAL IMPLANT WAS INSERTED BY FLEXED POSITION, AND THE TIBIAL IMPLANT WAS TILTED MEDIAL SIDE. THE IMPLANTS WERE LOOSED, SO THE SURGEON REMOVED THEM EASILY AND INSERTED NEW IMPLANTS. THE REVISION SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE SURGEON THOUGHT THAT IT WAS TECHNICAL ERROR BY THE PRIMARY SURGERY¿S SURGEON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10482149 ↗
• InjuryApr 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2009 VIA TKA FOR THE PATIENT¿S LEFT KNEE. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE FEMORAL COMPONENT (P/N: 950012), THE TIBIAL INSERT (P/N: 951020) AND THE TIBIAL TRAY (P/N: 129433120) DUE TO LOOSENING. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9922139 ↗