BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 16631585 · Received March 28, 2023

    Report

    Report Number
    1038671-2023-00527
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    January 1, 2021
    Report Date
    February 3, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304100
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 6061609 02-010-06-0220 - LOGIC CC FEMORAL SIZE 2, LEFT, 6366036 02-012-61-4000 - LOGIC OFFSET STEM EXT COUPLER 4MM, 6366053 02-012-61-4000 - LOGIC OFFSET STEM EXT COUPLER 4MM, 6135451 02-012-64-1280 - TRU FLUTED STM EXT 12MM X 80MM BLAST, 6326926 02-012-64-1280 - TRU FLUTED STM EXT 12MM X 80MM BLAST, 6275482 02-022-45-2020 - TRULIANT TIB FIT TRAY CEM SZ 2F / 2T, 6580336 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 6580449 204-70-00 - TIBIAL STEM EXT. SCREW, 6174947 208-05-02 - CC DISTAL FEM AUGMENT SZ 2, 5MM, 6536532 208-05-02 - CC DISTAL FEM AUGMENT SZ 2, 5MM.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 54 YO FEMALE PATIENT WAS EXPERIENCING SYNOVITIS AND FIXED FLEXION DEFORMITY CAUSING CONSTANT PAIN AND SWELLING. BONE SCAN SHOWS INCREASED UPTAKE AROUND TIBIOFEMORAL AND PATELLAR COMPONENTS ON THE LEFT. THE DATE OF ADVERSE EVENT ONSET IS UNK-UNK-2021. REVISION WAS RECOMMENDED AND SCHEDULED FOR (B)(6) 2021 BUT WAS DEFERRED BECAUSE HEMOGLOBIN A1C WAS >11 WHICH IS NOW BETTER CONTROLLED. THEREFORE, THE PATIENT WAS RESCHEDULED AND REVISED ON (B)(6) 2023. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480961 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. UNK UNK 10885862304100

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other| R