P.F.C. SIGMA 96-0868Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295234319), received between Dec 15, 2017 and Mar 13, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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 18 most recent of 18 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 21596983 ↗
• InjuryMar 15, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE BOLT INTERFACE. DOI: (B)(6) 2017; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18912007 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A FIRST STAGE REVISION FOR INFECTION. TC3 IMPLANTS INSITU WHICH WERE REMOVED AND A CEMENT SPACER REPLACED. REVISION WILL BE BOOKED ONCE INFECTION CLEARS. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18785449 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A FIRST STAGE REVISION FOR INFECTION. TC3 IMPLANTS INSITU WHICH WERE REMOVED AND A CEMENT SPACER REPLACED. REVISION WILL BE BOOKED ONCE INFECTION CLEARS. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18785446 ↗
• InjurySep 25, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS IDENTIFIED THAT ON (B)(6) 2023, THERE WAS A REPORT FOR ASEPTIC LOOSENING LEFT REVISION (KNEE HAS BEEN REVISED IN THE PAST). DOI: (B)(6) 2002. DOR: UNKNOWN. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17807205 ↗
• InjurySep 20, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS IDENTIFIED THAT ON (B)(6) 2023, THERE WAS A REPORT FOR ASEPTIC LOOSENING LEFT REVISION (KNEE HAS BEEN REVISED IN THE PAST). DOI: (B)(6) 2013, DOR: UNKNOWN, LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17781318 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 17539938 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TORN MCL AND PCL AND INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: THICKER IMPLANT REQUIRED WITH AUGMENTATION.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17224171 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT RESECTION WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14141975 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR A DISLOCATED TC3 RP REVISION KNEE. PATIENT'S SOFT-TISSUE WAS DISCOVERED TO BE COMPROMISED UPON EXPOSURE OF THE JOINT. THE PATIENT WAS REVISED TO AN SROM HINGE WITHOUT ISSUE. THE INSERT WAS STILL IN THE TRAY AND DID NOT SPIN 90 DEGREES. THE FEMUR DISLOCATED DUE TO SOFT TISSUE INJURY.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 11505027 ↗
• InjuryFeb 26, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO BONE AND CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2018 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11388340 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS FROM (B)(6) 2020 NOTE THAT THE PATIENT WENT THE ER DUE TO WORSENING LEFT KNEE PAIN AND GOT AN INJECTION OF TORADOL. DOI: (B)(6) 2016. DOR: (B)(6) 2017. (CAPTURED IN (B)(4)). DOE: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10582993 ↗
• 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 10291864 ↗
• InjuryFeb 6, 2019Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO FEMORAL COMPONENT MIGRATION; METAL/NICKEL ALLERGY.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 8311043 ↗
• InjuryJul 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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: Not Applicable; Unspecified Infection

  MAUDE report 7671125 ↗
• InjuryJul 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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: Not Applicable; Unspecified Infection

  MAUDE report 7671065 ↗
• InjuryDec 15, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2004. DOR: (B)(6) 2017. RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7120748 ↗
• InjuryDec 15, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2004; DOR: (B)(6); 2017 RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7120700 ↗