BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HINTERMANN SERIES H3

    MDR report key: 23089095 · Received September 18, 2025

    Report

    Report Number
    3012104767-2025-00002
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    October 22, 2024
    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 REPORTED CONTINUED PAIN AND WAS DIAGNOSED WITH TIBIAL NON-UNION. REVISION SURGERY WAS COMPLETED (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2843337 HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT NTG DT MEDTECH, LLC 302205 AABOI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention