P.F.C. SIGMA 96-0888Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295234418), received between Nov 2, 2017 and Feb 10, 2026 — classified as 39 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (14 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE FEMORAL COMPONENT CAME LOOSE AND WAS EASILY REMOVED DURING SURGERY. DR. DID IMPACTING GRAFTING AND RE IMPLANTED A NEW FEMUR WITH LONG TAPERED STEM.

  Patient problems: Insufficient Information

  MAUDE report 24301592 ↗
• InjuryJan 12, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT A FEMORAL REVISION PERFORMED DUE TO LOOSENING OF THE FEMORAL COMPARTMENT. LOOSING OCCURRED AT THE FEMORAL ADAPTER AND SLEEVE JUNCTION. THERE WAS NO SURGICAL DELAY. DOI: ON (B)(6) 2016, DOE: ON (B)(6) 2025, AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 24039340 ↗
• MalfunctionOct 21, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING THE SURGERY, THE DEVICE COULD NOT BE INSTALLED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348556 ↗
• InjuryApr 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POSSIBLE ASEPTIC LOOSENING. REMOVED ALL IMPLANTS AND CONVERTED TO ATTUNE REVISION KNEE IMPLANTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21892741 ↗
• 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 18002559 ↗
• 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 17044199 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND STERLING AND WAS TESTED FOR NICKEL ALLERGY. THE TEST CAME BACK POSITIVE SO THE SURGEON TOOK IT ALL OUT AND PUT IN AN AESCULAP REVISION CONSTRUCT. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16584804 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND STERLING AND WAS TESTED FOR NICKEL ALLERGY. THE TEST CAME BACK POSITIVE SO THE SURGEON TOOK IT ALL OUT AND PUT IN AN AESCULAP REVISION CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16584735 ↗
• InjuryDec 22, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE UNKNOWN COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT BROKE THE ADAPTOR AND ADAPTOR BOLT FOR THE SECOND TIME. BONE HAS RESORBED AROUND THE IMPLANT CREATING ALMOST A DISTAL FEMORAL REPLACEMENT SITUATION. ADAPTOR BOLT, ADAPTOR, FEMORAL COMPONENT AND INSERT WERE REMOVED LEAVING THE TIBIAL COMPONENT AND FEMORAL SLEEVE AND STEM WELL FIXED IN THE PATIENT. A HINGED COMPONENT WAS THEN PREPPED FOR AND IMPACTED INTO THE SLEEVE THAT WAS WELL FIXED IN THE BONE AND A LPS INSERT WAS INSERTED. DOI: (B)(6) 2017. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16033312 ↗
• 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 INTRAVENOUS 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 16017390 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED PATIENT WAS UNSTABLE. THE SURGEON REMOVED THE FEMORAL COMPONENTS/POLY AND REPLACED FEMORAL COMPONENTS/POLY. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15910374 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT KNEE. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15586812 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT KNEE. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15586794 ↗
• 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 15011802 ↗
• 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 15011794 ↗
• 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 12437034 ↗
• 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 12437032 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BONE FRACTURE OF MEDIAL AND LATERAL FEMORAL CONDLYLES: ABNORMAL RADIOGRAPHIC EVALUATION - LIKELY FEMORAL COMPONENT LOOSENING (UNCONFIRMED), WITH FRACTURE OF THE MEDIAL AND LATERAL CONDYLES, AND INSTABILITY EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF REVISION: (B)(6) 2017 (ALL COMPONENTS). DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: REVISION OF THE FEMORAL AND INSERT COMPONENTS OCCURRED ON (B)(6) 2021.

  Patient problems: Fall; Joint Laxity; Limb Fracture; Pain; Swelling/ Edema

  MAUDE report 12415377 ↗
• 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 12337184 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TKA. REMOVED IMPLANTS THAT WERE IMPLANTED (B)(6) 2020. PERFORMED WASHOUT, I&D AND IMPLANTED A ANTIBIOTIC CEMENT SPACER. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 12296499 ↗
• InjuryMay 27, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  "THE ABOVE MENTIONED KNEE ENDOPROSTHESIS WAS IMPLANTED IN (B)(6) IN 2002. SINCE 2013 LOOSENING OF THE PROSTHESIS AND FRACTURE OF THE TIBIAL STEM IS KNOWN. DUE TO MULTIPLE INTERNAL DISEASES THE PATIENT WAS NOT ABLE TO UNDERGO SURGERY UP TO NOW. NOW, KNEE-TEP REMOVAL WAS PERFORMED BECAUSE OF KNEE-TEP LOOSENING AND STEM-FRACTURE." DOI: (B)(6) 2002. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11893275 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. CONVERT TO ANTIBIOTIC SPACER. A DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11820279 ↗
• 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 11804834 ↗
• 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 11804832 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE TOTAL REVISION DUE TO MULTIPLE ISSUES INVOLVING AN UNKNOWN MANUFACTURER KNEE SYSTEM. DEPUY PRODUCTS AND CEMENT WERE USED DURING THE OPERATION. THE SURGEON NOTED WHILE IMPLANTING THE TIBIAL COMPONENT THE CREATION OF A SMALL CRACK ANTERIOR MEDIAL IN THE TIBIA. IT WAS LESS THAN A MILLIMETER. IT WAS EXTREMELY STABLE AND DID NOT REQUIRE FIXATION OR INTERVENTION. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH REMOVAL OF RIGHT TOTAL KNEE IMPLANTS, ALL COMPONENTS, COMPLETE SYNOVECTOMY AND AGGRESSIVE DEBRIDEMENT, AND PLACEMENT OF TEMPORARY ANTIBIOTIC LOADED SPACER CONTAINING GENTAMICIN AND VANCOMYCIN ANTIBIOTIC TO ADDRESS RECURRENT INFECTION. THE SURGEON NOTED THE REMOVAL OF FIBROUS TISSUE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11687527 ↗