BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HINTERMANN SERIES H2 TIBIAL ASSEMBLY

    MDR report key: 8400559 · Received March 7, 2019

    Report

    Report Number
    3012104767-2019-00001
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    February 6, 2019
    Report Date
    March 8, 2019
    Manufacturer
    DT MEDTECH, LLC
    Product Code
    HSN
    UDI-DI
    00+B0953228051
    PMA / PMN Number
    K171004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    POST-OP 10 MONTHS X-RAY SHOWED LOCK POSITION HAD CHANGED. PATIENT WAS ASYMPTOMATIC. SURGEON DECIDED TO DO A POLY SWAP AND FOUND THAT HE HAD NOT PROPERLY LOCKED THE CONSTRUCT. SURGERY WAS SUCCESSFUL. PATIENT POST-OP ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193835 HINTERMANN SERIES H2 TIBIAL ASSEMBLY ANKLE, TIBIAL COMPONENT HSN DT MEDTECH, LLC 322805 AAAJK 00+B0953228051

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention