BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HINTERMANN SERIES H3

    MDR report key: 20351870 · Received October 2, 2024

    Report

    Report Number
    3012104767-2024-00001
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    March 27, 2024
    Report Date
    September 4, 2024
    Manufacturer
    DT MEDTECH, LLC
    Product Code
    NTG
    PMA / PMN Number
    P160036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    SURGEON NOTICED VIA CT SCAN THAT THE PE INLAY HAD DISLOCATED. PATIENT WAS 2 MONTHS POST-OP WITH A RIGHT ANKLE REPLACEMENT REDACTED OP REPORT IS DOCUMENTED WITH REVISION OF PE INLAY DOS (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35530 HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT NTG DT MEDTECH, LLC 300205 AABII

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention