P.F.C. SIGMA 95-1031Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295230380), received between Jan 14, 2022 and Dec 16, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PFC SIG RPF INS SZ 3 12.5MM, UNKNOWN KNEE TIBIAL TRAY, AND UNKNOWN KNEE FEMORAL WERE INVOLVED IN A REPORTED EVENT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE. THE PATIENT HAD A HISTORY OF MULTIPLE FALLS AND POSSIBLE JOINT INSTABILITY. DURING REVISION SURGERY, THE FEMUR AND TIBIA WERE FOUND TO BE WELL FIXED WITH GOOD BONE AND CEMENT INTEGRATION, AND THE POLY INSERT DID NOT SHOW ABNORMAL WEAR OR OSTEOLYSIS. EXTENSION AND FLEXION WERE OPENING APPROXIMATELY 3-4MM EACH, AND THERE WAS EXCESSIVE BONE GROWTH OVER THE PATELLA AND TIBIAL BASE PLATE. THE FEMUR, TIBIA, AND POLY INSERT WERE REMOVED, WHILE THE ORIGINAL DOME PATELLA REMAINED UNTOUCHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY, NO FRAGMENTS WERE GENERATED, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. ALL THREE DEVICES WERE EXPLANTED DURING THE PROCEDURE.

  Patient problems: Bone Notching; Fall; Joint Laxity

  MAUDE report 23818839 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY WASHOUT AND REPLACEMENT DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 22519295 ↗
• InjuryDec 8, 2022Naturally Worn; Naturally Worn

  PATIENT REQUIRED REVISION KNEE SURGERY FOR AN UNSTABLE TIBIAL INSERT & WORN PATELLA. ON OPENING THE JOINT, THE PATELLA SHOWED SOME WEAR & YELLOW DISCOLORATION INDICATIVE OF POLY WEAR. WHEN THE JOINT WAS DISTRACTED MEDICALLY, THERE WAS SOME GAPPING. ON REMOVAL OF TIBIAL INSERT IT ALSO SHOWED SOME WEAR ON THE POSTERIOR MEDIAL SIDE. A NEW INSERT & PATELLA IMPLANT WERE INSERTED. PATIENT HAD GOOD ROM & WAS STABLE AT CONCLUSION OF SURGERY

  Patient problems: Joint Laxity

  MAUDE report 15939623 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT THE SURGERY WITH RPF INSERT IN QUESTION. AFTER THE SURGERY IT WAS CONFIRMED THAT A PERIPROSTHETIC JOINT INFECTION OCCURRED. REMOVAL SURGERY WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 13261894 ↗