BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 8865844 · Received August 6, 2019

    Report

    Report Number
    1038671-2019-00402
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 17, 2019
    Report Date
    October 31, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE ENGINEERING EVALUATION NOTED THAT EVENT REPORTED WAS LIKELY THE RESULT OF EITHER THE PATIENT¿S ANATOMY, TIBIAL TRAY TRIAL POSITIONING, OR A COMBINATION OF THE TWO.

    Description of Event or Problem · 0

    DURING PINNING THE RIGHT TIBIAL TRAY TRIAL TO THE TIBIA USING THE POSTERIOR PIN HOLES, THE MEDIAL PIN CAUSED A FRACTURE OF THE MEDIAL TIBIAL CORTEX. A SMALL CHIP OF BONE BROKE OFF. REPAIR OF THE BONE WAS NOT PERFORMED AS THE FRACTURE WAS NOT LARGE ENOUGH TO REPAIR. NO DELAY WAS REPORTED. PATIENT OUTCOME WAS GOOD. PATIENT WAS STABLE, THE X-RAYS LOOK GOOD, AND THE SURGEON DOESN¿T EXPECT ANY NEGATIVE CLINICAL OUTCOME. DEVICES ARE NOT BEING RETURNED.

    Additional Manufacturer Narrative · 1

    REPORTABLE EVENT: PENDING EVALUATION.

    Description of Event or Problem · 1

    DURING PINNING THE TIBIAL TRAY TRIAL TO THE TIBIA USING THE POSTERIOR PIN HOLES, THE MEDIAL PIN CAUSED A FRACTURE OF THE MEDIAL TIBIAL CORTEX. A SMALL CHIP OF BONE BROKE OFF. REPAIR OF THE BONE WAS NOT PERFORMED AS THE FRACTURE WAS NOT LARGE ENOUGH TO REPAIR. NO DELAY WAS REPORTED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659396 TRULIANT TRULIANT POROUS BASEPLATE SIZE 2 LXH EXACTECH, INC. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1