P.F.C. SIGMA 96-2144Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295241348), received between Mar 13, 2020 and Jun 6, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S OLD POLY EXCHANGED FOR INSTABILITY. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22158366 ↗
• InjuryOct 25, 2023Naturally Worn; Naturally Worn

  PT HAD HER KNEE DONE 18 YEARS AGO. POLY HAD WORN OUT POSTERIORLY. TOOK OUT THE POLY AND THEN UPSIZED FROM 17.5 TO 22.5. DOCTOR WAS HAPPY WITH STABILITY. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18004736 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D OF KNEE WITH POLY SWAP. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15797003 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN UNSTABLE KNEE. SURGEON EXPLANTED TIBIA REVISING WITH NEW MBT REV TRAY. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15640317 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED FOR INFECTION. SPACER PLACED. NOTHING FURTHER TO REPORT, NO SURGICAL DELAY, NO LOOSENING. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15527945 ↗
• InjuryMar 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. NO SURGICAL DELAY. DOI: 2014; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13851995 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS KNEE INFECTION. POLY WAS REMOVED. NO SURGICAL DELAY. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2019; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11693351 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LIMITED MOTION DUE TO ROM AT +20 DEGREE TO 75 DEGREE. OSTEOPHYTES EXCISED AND NEW INSERT IMPLANTED. DOI: (B)(6) 2007, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 11558762 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. THE SURGEON REMOVED ALL COMPONENTS AND REPLACED WITH A ATTUNE REVISION TO CORRECT INSTABILITY. BACK IN 2009 WAS THE ORIGINAL SURGERY DATE, AND LATER REVISED ON (B)(6) 2015. NO ACCESS TO ANY OF THE INFORMATION FROM THE REVISION SURGERY. THE FEMUR WAS FROM THE ORIGINAL SURGERY AND THE TIBIA WAS REVISED IN 2015. NO SURGICAL DELAY. DOI: 2009 (FEMORAL COMPONENT). DOI: (B)(6) 2015 (TIBIAL COMPONENT). DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11243072 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2008, DATE OF REVISION: (B)(6) 2008, (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: No Code Available

  MAUDE report 10869288 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OF A REVISION FROM A PREVIOUS INFECTION. NO OTHER INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9830129 ↗