P.F.C. SIGMA 96-0880Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295234364), received between Sep 5, 2017 and Apr 24, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEPTIC A LOOSENING. IT WAS STATED THAT FEMUR/TIBIA WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS UNKNOWN. DOI: (B)(6) 2017. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24981928 ↗
• InjuryOct 25, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. REVISED FEMUR AND TIBIAL COMPONENTS. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18002547 ↗
• InjuryOct 25, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. REVISED FEMUR AND TIBIAL COMPONENTS. DOI: (B)(6), 2018. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18002545 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS EXPLANTED TC3 CONSTRUCT DUE TO NICKEL ALLERGY. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17490583 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE PAIN. EVENT IS NOT SERIOUS. DATE OF IMPLANT: (B)(6) 2010. DATE OF REVISION: (B)(6) 2013. DATE OF EVENT: (B)(6) 2011. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 17412723 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE PAIN. EVENT IS NOT SERIOUS: DATE OF IMPLANT: (B)(6) 2010, DATE OF REVISION: (B)(6) 2013, DATE OF EVENT: (B)(6) 2011. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 17412645 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INSTABILITY. DOI: (B)(6) 2017; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17044237 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TC3 REVISION KNEE? INFECTED, UNSTABLE. SIGNASURE CAME BACK NEGATIVE FOR INFECTION. PREVIOUS IV DRUG ABUSER, HIGH FUNCTIONING KNEE. PLAN A: ATTUNE REVISION, PLAN B: ATTUNE HINGE, AND PLAN C: TC3 FEMUR REVISION IF TIBIA WELL FIXED. IN SITU: TC3 FEMUR SIZE 4 PLUS DISTAL AND POSTERIOR AUGMENTS, STEM AND ADAPTOR, MBT TIBIA REVISION SIZE 3, WEDGE, STEM, SIZE 4 20MM INSERT TC3 RP AND PATELLA 41MM 3 PEG.

  Patient problems: Joint Laxity

  MAUDE report 16017396 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY AND KNEE GIVING OUT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017. DATE OF REVISION: UNKNOWN. DATE OF EVENT: (B)(6) 2022. LEFT KNEE. TREATMENT: REVISION COMPLETED. ALL COMPONENTS WERE REVISED.

  Patient problems: Joint Laxity

  MAUDE report 15011804 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY AND KNEE GIVING OUT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017. DATE OF REVISION: UNKNOWN. DATE OF EVENT: (B)(6) 2022. LEFT KNEE. TREATMENT: REVISION COMPLETED. ALL COMPONENTS WERE REVISED.

  Patient problems: Joint Laxity

  MAUDE report 15011800 ↗
• InjuryApr 12, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14084452 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN. SURGEON NOTED LOOSENING OF THE PFC SIGMA FEMORAL ADAPTER AND PFC SIGMA BOLT. THE BOLT BROKE AND DISASSOCIATED FROM THE ADAPTER. THE FEMUR WAS EASILY REMOVED AND THE ADAPTER WAS TURNED LOOSE. THE REMAINING BOLT WAS REMOVED FROM THE EXISTING FEMORAL SLEEVE VIA A THREADED EXTRACTOR IN THE REVISION KNEE REMOVAL SYSTEM. ALL COMPONENTS WERE REMOVED. THE SURGEON THEN SUCCESSFULLY COMPLETED CONVERTING TO A HINGE FEMUR. PATIENT HAD EXISTING TC3 REVISION CONSTRUCT IN LEFT KNEE. DOI: (B)(6) 2017; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12437028 ↗
• InjuryAug 18, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ORIGINAL OPERATION WAS PERFORMED (B)(6) 2017. TIBIA WAS LEFT IN THE PATIENT. SURGEON REPLACED THE IMPLANTS WITH ANOTHER TC3 FEMUR, SLEEVE AND A BIGGER PRESSFIT STEM. THE PROCEDURE TOOK 3 ½ HOURS. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 12337186 ↗
• InjuryAug 18, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ORIGINAL OPERATION WAS PERFORMED (B)(6) 2017. TIBIA WAS LEFT IN THE PATIENT. SURGEON REPLACED THE IMPLANTS WITH ANOTHER TC3 FEMUR, SLEEVE AND A BIGGER PRESSFIT STEM. THE PROCEDURE TOOK 3 ½ HOURS. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 12337137 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND POSSIBLE ROTATION OF IMPLANTS. NO LOOSENING WAS REPORTED. DOI: (B)(6) 2019; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11804831 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO END OF STEM PAIN. THE SURGEON REVISED THE ENTIRE CONSTRUCT TO A COMPETITIVE COMPANY. A DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11462609 ↗
• InjurySep 29, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY, EFFUSION, PAIN, DISCOMFORT, FEMORAL COMPONENT MIGRATION AND LOOSENING AT AN UNKNOWN INTERFACE, TIBIAL TRAY LOOSENING AT AN UNKNOWN INTERFACE, AND NO INGROWTH OF THE TIBIAL OR FEMORAL SLEEVES. THE UNKNOWN MANUFACTURER PATELLAR COMPONENT WAS RETAINED. ALL OTHER COMPONENTS WERE REVISED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Discomfort; Edema; No Code Available; Pain

  MAUDE report 10600384 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS UNSTABLE AND NEEDS TO CONVERT TO HINGE. THE SALES REP DO NOT HAVE THE EXACT DATE OF SURGERY AND ENTERED (B)(6) 2011 INSTEAD. THE SURGEON STATED THAT THE PART OF THE PS POST ON THE TC3 POLY WAS BROKEN OFF. SURGEON KNOCKED FEMORAL COMPONENT OFF, LEAVING THE SLEEVE AND STEM IN THE FEMUR. THE TIBIAL COMPONENTS ALSO STAYED IN. NO SURGICAL DELAY. DOI: (B)(6) 2011; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10298832 ↗
• InjurySep 5, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND ASEPTIC LOOSENING OF THE FEMORAL AND TIBIA AT THE UNKNOWN INTERFACE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 6843011 ↗