BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HINTERMANN SERIES H2 TIBIAL ASSEMBLY

    MDR report key: 10222331 · Received July 1, 2020

    Report

    Report Number
    3012104767-2020-00001
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    June 3, 2020
    Report Date
    July 1, 2020
    Manufacturer
    DT MEDTECH, LLC
    Product Code
    HSN
    UDI-DI
    +B095321804
    PMA / PMN Number
    K171004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    POST-OP 22 MONTHS X-RAY SHOWED LOCK POSITION HAD CHANGED. ON (B)(6), DT MEDTECH WAS MADE AWARE OF A PLANNED REVISION. SURGEON PERFORMED THE REVISION ON (B)(6) 2020 AND FOUND THAT THE LOCKING ARMS WERE BROKEN. SURGERY WAS SUCCESSFUL. PATIENT POST-OP ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680567 HINTERMANN SERIES H2 TIBIAL ASSEMBLY ANKLE, TIBIAL COMPONENT HSN DT MEDTECH, LLC 321804 AAAJC +B095321804

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention