NA 86-7412Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295217817), received between Nov 9, 2017 and Sep 9, 2025 — classified as 43 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO INFECTION, THE HING SYSTEM WAS REMOVED ENTIRELY. THERE WAS NO ASEPTIC LOOSENING AND THE SYSTEM WAS WELL FIXED. AFTER REMOVING THE HINGE PIN AND POLYETHYLENE LINER THEY DISIMPACTED THE FEMORAL COMPONENT AND DISRUPTED THE TAPER ENGAGEMENT, LEAVING THE SLEEVE AND STEM BEHIND. AFTER REMOVING THE FEMUR, THEY WORKED TO REMOVE FEMORAL SLEEVE AND DISTAL STEM AND MANAGED TO WITHOUT SUBSTANTIAL BONE LOSS. AFTER REMOVING THE FEMORAL COMPONENT, THEY RESECTED BELOW THE TIBIAL COMPONENT AND KNOCKED IT LOOSE, REMOVING THE ENTIRE CONSTRUCT. AFTER THOROUGHLY WASHING OUT THE JOINT THEY PLACED A CEMENT SPACER TO LET THE INFECTION SUBSIDE. THE CASE TOOK APPROXIMATELY 90 MINUETS AND THERE WAS NO HARM DONE TO THE PT. ALL AVAILABLE INFORMATION WAS DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23001227 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MBT BASE PLATE WAS SUBSIDED AND FRACTURED PROXIMAL. THE TIBIA WAS LOOSE AND CAME OUT FAIRLY EASILY. THE SURGEON REMOVED THE BASE PLATE, SLEEVE AND STEM. ONLY ONE STEM WAS REVISED. HE REPLACED THIS WITH AN ATTUNE BASE PLATE STEEL AND AUGMENTS. TIBIA LOOSENING INTERFACE: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22338936 ↗
• InjuryJun 13, 2024Loss of or Failure to Bond; Osseointegration Problem; Loss of or Failure to Bond; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED: A. IT WAS INDICATED THAT THERE WAS LOOSENING. ON WHAT INTERFACE DID THE LOOSENING OCCURRED? CEMENT BONE B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO C. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? RIGHT D. WAS THERE ANY ALLEGATION AGAINST THE TIBIAL COMPONENT? NO E. CAN YOU CONFIRM IF DEPUY CEMENT WAS USED DURING THE PRIMARY SURGERY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS OF THE CEMENT. QUANTITY OF THE DEPUY CEMENT USED. NO.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 19527574 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. A. PLEASE CONFIRM, WHAT IMPLANTS WERE MISPOSITIONED? FEMORAL COMPONENT AND TIBIAL TRAY. B. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO, DUE TO THE MISPOSITIONING OF THE IMPLANTS. C. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. D. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, ALL CORRECT SIZING. E. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED, DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, REPORTED AS OKAY. F. WAS THERE A SURGICAL DELAY, BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Joint Laxity

  MAUDE report 19261612 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. A. PLEASE CONFIRM, WHAT IMPLANTS WERE MISPOSITIONED? FEMORAL COMPONENT AND TIBIAL TRAY. B. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO, DUE TO THE MISPOSITIONING OF THE IMPLANTS. C. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. D. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY, THAT LED TO THE INSTABILITY? NO, ALL CORRECT SIZING. E. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED, DURING THE PRIMARY SURGERY, THAT LED TO THE INSTABILITY? NO, REPORTED AS OKAY. F. WAS THERE A SURGICAL DELAY, BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Joint Laxity

  MAUDE report 19261611 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE : UNKNOWN.

  Patient problems: Pain

  MAUDE report 18856583 ↗
• 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 18785448 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED LEFT TOTAL KNEE. IMPLANTED DFR ON (B)(6), 2023 AND A POLY EXCHANGE ON (B)(6), 2023. PATIENT CAME INFECTED SO THEY EXPLANTED ALL IMPLANTS AND IMPLANTED A CEMENT SPACER USING ANTIBIOTIC SPACER AND EX-FIX RODS AND CONNECTOR. DOI: (B)(6), 2023. DOR: (B)(6), 2024. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 18776702 ↗
• InjurySep 25, 2023Osseointegration Problem; Osseointegration Problem

  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: Inadequate Osseointegration

  MAUDE report 17807235 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD REVISION SIGMA COMPONENTS CURRENTLY IMPLANTED BUT THE TIBIAL COMPONENT HAD FALLEN INTO VARUS AND THE TIBIAL STEM WAS PROTRUDING OUT OF THE LATERAL CORTEX OF THE TIBIA. THIS PATIENT ALSO HAD STABILITY ISSUES SO SURGEON REMOVED BOTH THE TIBIAL AND FEMORAL COMPONENTS AND REPLACED THEM WITH AN ATTUNE REVISION TIBIAL TRAY, STEM, AND SLEEVE. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 17443711 ↗
• InjuryMar 13, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT (NON CEMENTED). DISTAL FEMORAL REPLACEMENT DONE. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16529040 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TOTAL KNEE EXPLANT WAS PERFORMED DUE TO KNEE JOINT INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014, DOR: (B)(6) 2022, AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15983807 ↗
• InjuryMay 20, 2022Osseointegration Problem; Osseointegration Problem

  REVISION LEFT TOTAL KNEE FOR LOOSE TIBIAL COMPONENT. IT IS UNDERSTOOD PATIENT HAD A PREVIOUS TIBIAL PLATEAU FRACTURE IN NATIVE KNEE PRIOR TO COMPLEX PRIMARY TOTAL KNEE REPLACEMENT. TIBIAL COMPONENT METAPHYSEAL SLEEVE AND TIBIAL STEM LOOSE THUS REMOVED AND REVISED. NATIVE PATELLA RESURFACED AT TIME OF REVISION. PRIMARY 31.5.18 DOI: (B)(6) 2018; DOR: (B)(6) 2022; LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14453620 ↗
• InjuryMar 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED LEFT KNEE. EXTRACTION OF COMPONENTS AND INSERTION OF ANTIBIOTIC SPACER WERE DONE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 13925416 ↗
• InjuryMar 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED LEFT KNEE. EXTRACTION OF COMPONENTS AND INSERTION OF ANTIBIOTIC SPACER WERE DONE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 13925412 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION TKA AFTER AN INFECTION WITH A TC3 IMPLANTS PLACED ON (B)(6) 2020. SHE WAS RETURNED TO SURGERY TODAY DUE TO A REPEAT KNEE INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. ADDITIONAL PART USED AND REMOVED, NOT RETURNED 960784/J38U33 960861/HK5168 962343/HU0956. DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (RIGHT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 13043400 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO LOOSENING REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12719483 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO LOOSENING REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12719453 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAINFUL RIGHT TOTAL KNEE WITH CREPITANS, ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2010 (COMPETITOR KNEE SYSTEM), DATE OF REVISION #1: (B)(6) 2010 (REVISION OF COMPETITOR FEMUR, TIBIAL TRAY, INSERT - COMPETITOR PATELLA RETAINED), DATE OF EVENT (ONSET): (B)(6) 2013, (RIGHT KNEE). TREATMENT: SURGICAL ARTHROTOMY WITH EXCISION OF SCAR TISSUE.

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

  MAUDE report 12363726 ↗
• InjuryMay 7, 2021Fracture; Fracture

  PATIENT WAS REVISED DUE TO WITH ONSET IN PAIN AND LOOSENING OF THE FEMORAL SLEEVE AT THE BONE TO IMPLANT INTERFACE. X-RAYS REVEAL A BROKEN PROSTHESIS. PATIENT HAD A VERY TIGHT FEMORAL CANAL MAKING SURGEON BELIEVE THE STRESS WAS TRANSFERRED TO THE STEM AND LITTLE TO THE SLEEVE. AS SUCH, THE SLEEVE DID NOT IN GROW AND THE PROSTHESIS EVENTUALLY FAILED UNDER CYCLIC LOAD. PROSTHESIS WAS REMOVED AND REPLACED EVENTUALLY. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT KNEE. FURTHER INFORMATION PROVIDED THAT THE STEM BROKE AT THE STEM-SLEEVE JUNCTION.

  Patient problems: Pain

  MAUDE report 11792304 ↗
• InjuryApr 27, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF FEMORAL SLEEVE AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT DISTAL FEMORAL CONSTRUCT HAD NOT INGROWN TO SLEEVE AND MIGRATED PROXIMALLY IN THE FEMUR. SURGEON REMOVED PRESS FIT CONSTRUCT AND REPLACED WITH CEMENTED CONSTRUCT. TIBIA AND PATELLA WERE NOT ALTERED. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11732699 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2019; DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11455947 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PERIPROSTHETIC KNEE INFECTION. NO DELAY IN SURGERY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11398541 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RADIOLOGY REPORT (B)(6) 2017 (POST REVISION SURGERY) REVEALS THE HARDWARE APPEARS TO BE INTACT. THERE IS A REMOTE AVULSION FRACTURE OF THE MEDIAL ASPECT OF THE MEDIAL FEMORAL CONDYLE. THERE IS NO INDICATION OF TREATMENT RELATED TO THIS AVULSION FRACTURE. IT IS UNKNOWN WHEN THIS FRACTURE OCCURRED, DURING THE REMOVAL OF PREVIOUS IMPLANTS OR IMPLANTATION OF REVISION IMPLANTS. THEREFORE, THIS WILL NOT BE CAPTURED AS A SEPARATE EVENT. OFFICE NOTES (B)(6) 2017 ¿ (B)(6) 2020 INDICATE THE PATIENT CONTINUES TO EXPERIENCE PAIN, STIFFNESS, WEAKNESS, INSTABILITY, SWELLING AND LEG LENGTH DISCREPANCY. THE PATIENT ALSO STATES SHE HAS SKIN DISCOLORATION ON THE MEDIAL ASPECT OF HER LOWER LEG. IT IS INDICATED THE SURGEON HAS DISCUSSED THE POTENTIAL NEED FOR FUTURE REVISION, HOWEVER, THERE IS NO INDICATION AN ADDITIONAL REVISION SURGERY HAS TAKEN PLACE. IT IS INDICATED, HOWEVER, THAT THE PATIENT HAS RECEIVED PAIN BLOCK INJECTIONS DUE TO HER KNEE PAIN. A SHOE HEEL LIFT WAS PROVIDED TO HELP ADDRESS THE LEG LENGTH DISCREPANCY. WHOLE BODY BONE SCAN WAS PERFORMED ON (B)(6) 2019 REVEALS LOW-LEVEL ACTIVITY DIFFUSELY AROUND THE LEFT KNEE PROSTHETIC. NO SIGN OF OSTEOMYELITIS OR FRACTURE. DOI: (B)(6) 2016 (PAT

  Patient problems: Fatigue; Joint Laxity; Muscular Rigidity; Pain; Physical Asymmetry; Skin Discoloration; Swelling/ Edema

  MAUDE report 10927382 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS TIBIAL STEM PAIN. DOI: UNKNOWN, DOR: (B)(6) 2020, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10612931 ↗