P.F.C. SIGMA 95-1025Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295230335), received between Aug 16, 2018 and Oct 27, 2025 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ARTIFICIAL JOINT REPLACEMENT ON THE LIFT KNEE WITH THE PRODUCT IN QUESTION. AFTER THE SURGERY, ON (B)(6) 2025, THE SALES REP CONFIRMED BY THE SURGEON THAT INFECTION OCCURRED. REVISION SURGERY OCCURRED ON (B)(6) 2025. THE INSERT WAS REMOVED, THOROUGHLY CLEANED, AND THEN REPLACED WITH AN INSERT OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 23391468 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I&D AND INSERT EXCHANGE. THERE WAS NO SURGICAL DELAY. THERE WAS NO ALLEGATION AGAINST THE PRODUCT. NO ADVERSE EVENT WAS REPORTED BY THE SURGEON. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21907980 ↗
• InjuryJun 7, 2024Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO POLY WEAR. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2012 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19487202 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 19042929 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 18141685 ↗
• 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 14698583 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DECREASED RANGE OF MOTION : ADHESIONS. 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) 2016; DATE OF EVENT (ONSET): (B)(6) 2016; (RIGHT KNEE). TREATMENT: RIGHT KNEE MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 13288932 ↗
• InjuryFeb 8, 2021Naturally Worn; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS POLYETHYLENE WEAR AND INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2004, DATE OF REVISION: (B)(6) 2020, (LEFT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, AND TIBIAL INSERT REVISED.

  Patient problems: Joint Laxity

  MAUDE report 11294736 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  2008 WAS IMPLANTATION HOWEVER NO SPECIFIC DATE COULD BE OBTAINED. OPERATIVE SIDE LEFT

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9643958 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN, POSSIBLE INFECTION. CULTURES WAS OUT CLEAN AND SURGEON REVISED TO A TC3 KNEE REVISION. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7790617 ↗