BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRU CC TIB INSERT SIZE 2, 15MM

    MDR report key: 20086018 · Received August 28, 2024

    Report

    Report Number
    1038671-2024-03134
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    August 12, 2024
    Report Date
    August 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862265890
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 6641890, 02-010-06-0320 - TRU CC FEMORAL SIZE 2 RIGHT. 6931290, 02-012-45-2010 - LGC TIBIAL FIT TRAY CEM SZ 2F/1T. A323354, 02-012-60-1280 - TRU STEM EXT 12MM X 80MM. A207994, 02-012-60-1680 - TRU STEM EXT 16MM X 80MM. 6165557, 208-05-02 - CC DISTAL FEM AUGMENT SZ 2, 5MM. 6314557, 400-40-14 - FLEX OSTEOTOME-FLAT, NAR. A108900, 400-40-14 - FLEX OSTEOTOME-FLAT, NAR.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REPORTED REVISION DUE TO STIFFNESS CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO PATIENT FACTORS/ETIOLOGY, COMPONENT POSITIONING, ARTHROFIBROSIS, INFECTION AND/OR IMPLANT SELECTION. THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY ONE YEAR AGO THE PATIENT WAS REVISED FROM COMPETITOR DEVICES TO A CCK. RECENTLY, THE PATIENT CAME IN STIFF, SO WAS DOWNSIZED FROM A 15 CCK INSERT TO A 9 CCK INSERT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179771 TRU CC TIB INSERT SIZE 2, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862265890

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H11.