P.F.C. SIGMA RPF 95-0023Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295224099), received between Feb 9, 2018 and Apr 4, 2024 — 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.

• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2006. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19042918 ↗
• InjuryNov 21, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2019, THE PRIMARY SURGERY WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, ON AN UNKNOWN DATE, INFECTION WAS CONFIRMED. DETAILS SUCH AS THE CAUSE OF THE INFECTION AND PLANS FOR REOPERATION ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED: THERE WAS NO INFECTION. IT TURNED OUT TO BE FEMORAL DE-BONDING, SO THE IMPLANT WAS REMOVED ON (B)(6), 2023 AND REVISION SURGERY IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18180903 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S PRIMARY KNEE COMPONENTS WERE EXPLANTED (REMOVED) DUE TO INFECTION. THEY WERE REPLACED BY A TEMPORARY ANTIBIOTIC STATIC SPACER. DOI: (B)(6) 2018; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14698444 ↗
• InjurySep 6, 2019Loss of or Failure to Bond; Malposition of Device; Loss of or Failure to Bond; Malposition of Device

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, TIBIAL TRAY MALPOSITIONING, AND FEMORAL COMPONENT MALPOSITIONING AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED THE PATELLA COMPONENT WAS NOT ORIGINALLY PLACED PERFECTLY SYMMETRIC, BUT THE COMPONENT WAS LEFT INTACT TO AVOID SIGNIFICANT BONE LOSS WITH REMOVAL. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2008; DOR: (B)(6) 2010, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8969970 ↗
• InjuryFeb 9, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE, UNKNOWN CEMENT MANUFACTURER WAS USED. IT ALSO STATED THAT THE SURGEON THOUGHT SHE NEEDED A POLY SWAP, BUT ONCE HE WAS IN THERE HE REALIZED THE FEMUR WAS LOOSE. THE CEMENT CAME RIGHT OFF THE PROSTHESIS AND BONE. HE DOWNSIZED THE FEMUR FROM A 2.5 DOWN TO A 2. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN KNEE AFFECTED SIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7259823 ↗