BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HINTERMANN SERIES H3

    MDR report key: 23090009 · Received September 18, 2025

    Report

    Report Number
    3012104767-2025-00003
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    April 28, 2025
    Report Date
    September 18, 2025
    Manufacturer
    DT MEDTECH, LLC
    Product Code
    NTG
    PMA / PMN Number
    P160036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT INITIALLY IMPLANTED ON (B)(6) 2023. PATIENT DIAGNOSED WITH SUBLUXATION OF SUBTALAR JOINT AND TALAR COMPONENT OF THE IMPLANT REQUIRED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2840559 HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT NTG DT MEDTECH, LLC 301112 AABJY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention