P.F.C. SIGMA RPF 95-0015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295224037), received between Jul 13, 2017 and Feb 5, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 5, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT PRIMARY TOTAL KNEE ARTHROPLASTY (TKA) ON LEFT KNEE WITH THE PRODUCT IN QUESTION. POSTOPERATIVELY, LOOSENING WAS IDENTIFIED IN THE FEMORAL AND TIBIAL COMPONENTS, LEADING TO A REVISION TKA ON (B)(6) 2026. THE FEMORAL COMPONENT DETACHED EASILY UPON REMOVAL OF THE INSERT, AND SIGNIFICANT LOOSENING WAS ALSO OBSERVED IN THE TIBIAL TRAY, BOTH OF WHICH WERE REMOVED WITHOUT DIFFICULTY. THE REVISION WAS PERFORMED DUE TO FINDINGS OF LOOSENING AND SEVERE PAIN WITH EDEMA. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ALTERNATIVE PRODUCTS, AND THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24273908 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. IMPLANTING ATTUNE REVISION. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16859774 ↗
• InjuryJul 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6710028 ↗