P.F.C. SIGMA 96-0863Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295234296), received between Jul 9, 2018 and Mar 13, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Migration” (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.

• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL RIGHT KNEE. SURGEON CONVERTED FROM A TC3 TO DISTAL FEMORAL REPLACEMENT. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21596829 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. NO DELAY. DOI- (B)(6) 2020. DOR- (B)(6) 2023. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18119371 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16214057 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SIGNIFICANT FLEXION CONTRACTURE BUT INSTABILITY IN FLEXION. TIBIAL COMPONENTS REMOVED ALONG WITH FEMORAL COMPONENTS AND CONVERTED TO DISTAL FEMORAL REPLACEMENT ON EXISTING FEMORAL SLEEVE AND STEM. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11554914 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SIGNIFICANT FLEXION CONTRACTURE BUT INSTABILITY IN FLEXION. TIBIAL COMPONENTS REMOVED ALONG WITH FEMORAL COMPONENTS AND CONVERTED TO DISTAL FEMORAL REPLACEMENT ON EXISTING FEMORAL SLEEVE AND STEM. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018. DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11554905 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO MCL RUPTURE. REVISED FEMORAL COMPONENT AND TIBIAL POLY TO A SROM HINGE. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10291870 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A UNSTABLE KNEE AND NEEDED A CONVERSION TO A HINGE KNEE. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10162640 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE PATIENT ALSO UNDERWENT A POLY EXCHANGE FOR THE SAME REASON AT THIS HOSPITAL ON (B)(6) 2019 AND WAS CAPTURED IN (B)(4). DOI: (B)(6) 2019, (B)(6) 2019 (INSERT); DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9079009 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE PATIENT ALSO UNDERWENT A POLY EXCHANGE FOR THE SAME REASON AT THIS HOSPITAL ON (B)(6) 2019 AND WAS CAPTURED IN (B)(4). DOI: (B)(6) 2019, (B)(6) 2019 (INSERT), DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9078137 ↗
• InjuryJul 26, 2019Unintended Movement; Migration; Unintended Movement; Migration

  PATIENT WAS REVISED TO ADDRESS LATER SHIFT OF FEMORAL COMPONENT IN PATIENT WITH ABNORMAL FEMUR. SURGEON EXPLANTED FEMORAL COMPONENT AND REVISED WITH SIGMA TC3. DOI: UNK, DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8831691 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REVISED ALL KNEE COMPONENTS AND REMOVED. DOI: (B)(6) 20018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7670148 ↗