P.F.C. SIGMA 95-1041Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295230427), received between Jul 13, 2017 and Jan 13, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PLEASE CONFIRM THE PRIMARY CAUSE FOR THE REVISION? WAS IT INFECTION OR PATELLA FRACTURE? -IT WAS BOTH - FRACTURED PATELLA HAD BECOME INFECTED THUS THE POLY EXCHANGE. PATELLA IMPLANT NOT CHANGED AT THIS TIME.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 24057061 ↗
• InjurySep 19, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? YES, CORRECT.

  Patient problems: Joint Laxity

  MAUDE report 20257533 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF PFC FOR INSTABILITY. SURGEON STATED THE PROSTHESIS WAS NOT AT FAULT, RATHER THE KNEE WAS UNSTABLE AFTER PRIMARY JOINT REPLACEMENT IN 2010.

  Patient problems: Joint Laxity

  MAUDE report 16592253 ↗
• InjuryJul 21, 2021Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS INCREASING FEMORAL PAIN. FEMORAL AND PATELLA REVISION PERFORMED. OXIDATION AND WEAR WAS NOTED ON BOTH THE PATELLA AND POLYETHYLENE INSERT. FEMUR CAME OFF VERY EASILY, POSSIBLY WAS LOOSE AT THE IMPLANT/CEMENT INTERFACE. UNKNOWN BONE CEMENT WAS USED. PRODUCT CODES & LOT NUMBERS WERE UNAVAILABLE FOR COMPONENTS OTHER THAN THE INSERT. NO SURGICAL DELAY REPORTED. ORIGINAL IMPLANT DATE WAS SOMETIME IN 2005. DOI: 2005; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12204625 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SUPERFICIAL WOUND INFECTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015. DATE OF EVENT (ONSET): (B)(6) 2015. (LEFT KNEE). TREATMENT: INVASIVE KNEE ASPIRATION FOR CULTURES/SENSITIVITY INTRAVENOUS VANCOMYCIN ANTIBIOTIC THERAPY.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10817104 ↗
• InjuryJul 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6709957 ↗