BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HINTERMANN SERIES H2 TIBIAL SLIDE

    MDR report key: 11753644 · Received April 30, 2021

    Report

    Report Number
    3012104767-2021-00001
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 30, 2021
    Manufacturer
    DT MEDTECH, LLC
    Product Code
    HSN
    UDI-DI
    00+B0953218021
    PMA / PMN Number
    K171004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED REVERSION OF H2 TIBIAL SLIDE, H2 TIBIAL ASSEMBLY AND H2 POLY ASSEMBLY DUE TO X-RAY MALALIGNMENT. REVISION SURGERY WAS COMPLETED AND PATIENT OUTCOME IS SUCCESSFUL.

    Description of Event or Problem · 1

    REVISION SURGERY TO REPLACE H2 TIBIA SLIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652009 HINTERMANN SERIES H2 TIBIAL SLIDE TOTAL ANKLE REPLACEMENT HSN DT MEDTECH, LLC 321002 AAAJM 00+B0953218021

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention