P.F.C. SIGMA RPF 95-0026Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295224129), received between Feb 19, 2018 and Feb 15, 2021 — 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.

• InjuryFeb 15, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACES. THERE WAS LOOSENING AND SIGNIFICANT DELAMINATION OF THE PATELLA AND SOME ON THE TIBIAL INSERT. THE PATELLA WASN'T LOOSE, BUT THERE WAS LOOSENING ON THE TIBIAL TRAY AND FEMORAL COMPONENT. DEPUY CEMENT WAS USED. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2007, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11327627 ↗
• InjurySep 25, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PRIMARY IMPLANT DATE: (B)(6) 2007. REASON FOR REVISION: PAIN, LOOSENING AND INSTABILITY OF FEMORAL COMPONENT. ACTION TAKEN: REMOVAL OF PRIMARY IMPLANT. INSERTION OF NEW REVISION IMPLANTS.

  Patient problems: No Code Available; Pain

  MAUDE report 9120340 ↗
• InjuryFeb 19, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION RIGHT TKR DR (B)(6) HOSPITAL (B)(6) 2018 PRIMARY (B)(6) 2015 FOR RIGHT TKR THIS IS PATIENT'S FIRST REVISION: PRESENTED TO SURGEON WITH PAIN?INFECTION? ASEPTIC LOOSENING. ALL PRIMARY IMPLANTS AND BONE CEMENT REVISED AND PROCEED TO REVISION RIGHT TKR. MALE PATIENT (B)(6) YEARS OLD.

  Patient problems: Pain

  MAUDE report 7279728 ↗