BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE

    MDR report key: 24605221 · Received March 16, 2026

    Report

    Report Number
    1818910-2026-04843
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    September 9, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295042389
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMP LOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B5, B7, D1, D2A, D4 (LOT, CATALOG, EXPIRATION DATE, PRIMARY UDI), G4 (PMA/ 510(K)), H4, H6 (CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION, THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS REQUIRED AT THIS TIME. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. ADDED: D10 CONCOMITANT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING: UPDATE: MEDICAL RECORDS ENTITLED, ¿(B)(4) MEDICAL RECORD AD 24 MAR 2026¿ WERE REVIEWED BY A CLINICIAN. DOI: (B)(6) 2015: FEMALE PATIENT RECEIVED A LEFT ATTUNE TKA TO TREAT DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PRIMARY PART/LOT INFORMATION IS AVAILABLE ON PP. 1. DOR: (B)(6) 2022: 51-YEAR-OLD FEMALE PATIENT RECEIVED A LEFT KNEE ATTUNE TKA TO TREAT PAIN AND A SUBSIDED TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED SCAR TISSUE, SYNOVITIS, AND EDEMA. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE FEMORAL COMPONENT WAS LOOSENED AT THE CEMENT TO IMPLANT AND CEMENT TO BONE INTERFACE AND REVISED. THERE WAS EXTENSIVE FEMORAL OSTEOLYSIS AND INFLAMMATION. THE TIBIAL TRAY WAS LOOSENED AT AN UNKNOWN INTERFACE AND HAD MIGRATED AND WAS REVISED. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED AN ATTUNE REVISION CONSTRUCT WITH UNKNOWN CEMENT. DURING THE REVISION, THE FEMORAL AUGMENT DID NOT SEAT ON THE FEMORAL COMPONENT PROPERLY, WHICH CAUSED A FEMORAL CRACK WHEN THE SURGEON ATTEMPTED TO IMPLANT THE FEMORAL COMPONENT. THE AUGMENT WAS REPOSITIONED AND THE NEW FEMORAL COMPONENT SEATED APPROPRIATELY. THE CRACK WAS TREATED WITH A CERCLAGE CABLE. THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL COMPLICATIONS. DOE: (B)(6) 2023: 52-YEAR-OLD FEMALE PATIENT RECEIVED A LEFT KNEE MUA WITH CERCLAGE REMOVAL 8 MONTHS POST LEFT KNEE REVISION WITH A FEMORAL FRACTURE COMPLICATION TO TREAT PAIN, STIFFNESS, AND ARTHROFIBROSIS. THE UNKNOWN CERCLAGE WIRE WAS REMOVED AS THE FRACTURE HAD HEALED. SCAR TISSUE WAS DEBRIDED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2022 ((B)(4)). DOE: (B)(6) 2022 ((B)(4)- FEMORAL CRACK). DOE: (B))(6) 2023 (NEW EVENT). LEFT KNEE.

    Description of Event or Problem · 0

    ON (B)(6) 2015, PLAINTIFF UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. AFTER THE ATTUNE SYSTEM WAS IMPLANTED, PLAINTIFF BEGAN EXPERIENCING SEVERE AND PERSISTENT PAIN, DISCOMFORT, INSTABILITY AND DIFFICULTY AMBULATING CAUSED BY ASEPTIC LOOSENING OF THE DEFECTIVE ATTUNE TIBIAL BASEPLATE. ON (B)(6) 2022, PLAINTIFF UNDERWENT REVISION SURGERY DUE TO LOOSENING OF THE COMPONENTS OF THE ATTUNE SYSTEM IMPLANTED IN HER LEFT KNEE. DOI: (B)(6) 2015, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361093 ATTUNE KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US 8049212 10603295042389

    Patients

    Seq Age Sex Outcome Treatment
    1