P.F.C. SIGMA 86-6401Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295216896), received between Sep 8, 2017 and May 1, 2026 — classified as 35 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIAL COMPONENTS WERE REVISED FOR LOOSENING SECONDARY TO FRACTURE. TIBIA WAS LOOSE AT BONE TO CEMENT INTERFACE. CEMENT USED WAS FROM COMPETITOR BRAND. NO X-RAYS AVAILABLE. ALL KNOWN INFORMATION DISCLOSED. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 25058688 ↗
• InjuryAug 1, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TC3 TIBIA W/ STEM AND SLEEVE AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT¿S KNEE BECAME SEPTIC AND TIBIAL CONSTRUCT BECAME LOOSE. THE FEMUR, TIBIAL CONSTRUCT, POLY, AND PATELLA WERE EXTRACTED. PATELLA WAS NOT LISTED IN THE LIST OF IMPLANTS FROM INITIAL SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22687562 ↗
• MalfunctionJul 28, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE IS A DAMAGED PRODUCT. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630334 ↗
• InjuryOct 9, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PFC IMPLANTS WERE REVISED DUE TO SUSPECTED LOOSENING AT TIBIAL SURFACE.

  Patient problems: Joint Laxity

  MAUDE report 20409619 ↗
• InjurySep 17, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATES THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THE LOOSENING INTERFACE WAS IMPLANT/CEMENT FOR THE FEMUR, THE TIBIA AND FEMUR COMPONENTS WERE BOTH LOOSE.

  Patient problems: Insufficient Information

  MAUDE report 20235488 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO DELAYS.

  Patient problems: Unspecified Infection

  MAUDE report 18867256 ↗
• InjuryOct 19, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AT UNKNOWN INTERFACE. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17966051 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A REVISION SURGERY WAS PERFORMED DUE TO THE SUSPECTED INFECTION. THE SAID IMPLANTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2014. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17650269 ↗
• InjuryApr 28, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI- (B)(6) 2020. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16833352 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE SWELLING/HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2016. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: ASPIRATED FOR BLOOD AND MILD CLOUDINESS; SENT FOR SYNOVASURE AND CAME BACK NEGATIVE FOR BOTH AEROBIC AND ANAEROBIC ORGANISM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 16149976 ↗
• 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 15640233 ↗
• InjuryOct 14, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT THE SURGERY FOR LEFT OA VIA TKA WITH THE PCF IMPLANTS IN QUESTION, THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, LOOSENING OF THE IMPLANTS WAS CONFIRMED ON (B)(6) 2022. A REVISION SURGERY IS PLANNED ON (B)(6) 2022. THE CAUSE OF THE LOOSENING IS CONSIDERED TO BE THAT THE TIBIAL IMPLANT HAS SUNK DUE TO THE FRAGILE BONE QUALITY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15605662 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO UNKNOWN REASONS. PATIENT WAS REVISED TO A HINGE. NOTHING FURTHER TO REPORT. THE CEMENT MANUFACTURER WAS NOT INDICATED. NO LOOSENING EXPERIENCED. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15336466 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO KNEE INFECTION. ALL COMPONENTS REMOVED AND ANTIBIOTIC CEMENT SPACERS WERE IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. BONE CEMENT WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14213493 ↗
• InjuryJan 24, 2022Migration; Migration

  THE PATIENT WAS REVISED DUE TO TIBIA COLLAPSED ON THE MEDIAL SIDE AND CAUSED PATIENT DISCOMFORT AND INSTABILITY. THE DOCTOR REMOVED ALL COMPONENTS AND REPLACED WITH A NEW REVISION KNEE TO CORRECT PATIENTS INSTABILITY. DOI: (B)(6) 2008, DOR: (B)(6) 2022, LEFT SIDE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 13335042 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTED TOTAL KNEE. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED IN. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13177763 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT THE TKA SURGERY WITH PFC S IMPLANTS. AFTER THE SURGERY, ON (B)(6) 2021, THE INFECTION OCCURRED. REMOVAL OF THE IMPLANTS WAS PERFORMED ON (B)(6) 2021. THE SURGERY WAS COMPLETED SUCCESSFULLY NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12909705 ↗
• InjuryNov 7, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  TODAY A FULL NOILES CONSTRUCT WAS REVISED. THE REASON FOR THE REVISION WAS FOR ASEPTIC LOOSENING OF THE EXISTING IMPLANTS. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 12758545 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL & TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. REMOVAL OF ALL IMPLANTS DUE TO CEMENT COULDN'T SEE MOST NUMBERS. ONLY ABLE TO OBTAIN THE NUMBERS FROM FEMORAL STEM, TC3 RP INSERT AND THE THICK TRAY. ALL OTHER PARTS WERE COVERED BY CEMENT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12517241 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED. DOI: UNKNOWN, DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 12167663 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE 11TH REVISION AND REMOVAL OF ALL PREVIOUS REVISION COMPONENTS TO TREAT LEFT KNEE SWELLING AND CONFIRMED INFECTION. PATIENT RECEIVED A TEMPORARY ATTUNE ANTIBIOTIC SPACER TO BE REMOVED WHEN THE INFECTION HAS CLEARED. DOI: (B)(6) 2020 (10TH REVISION AND IMPLANTATION OF REVISION PRODUCTS); DOR: (B)(6) 2021 (11TH REVISION AND REMOVAL OF ALL PRODUCTS); LEFT KNEE.

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

  MAUDE report 12149702 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION OF THE LEFT KNEE. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11400070 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 11311457 ↗
• InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED VIA TKA ON (B)(6) 2011. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE SURGEON FOUND THAT THE SCREW OF THE EXPLANTED FEMORAL STEM¿S PART LOOSENED AND VERY WORE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10705312 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FLEXION INSTABILITY WITH HER PREVIOUS KNEE REPLACEMENT. SURGEON TIGHTENED HER FLEXION GAP WITH A TC3 FEMUR, +2 BOLT AND TC3 RP INSERT. DOI: (B)(6) 2015, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10461200 ↗