BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HINTERMANN SERIES H3

    MDR report key: 20113319 · Received August 30, 2024

    Report

    Report Number
    3012104767-2024-00002
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 29, 2024
    Manufacturer
    DT MEDTECH LLC, A VILEX COMPANY
    Product Code
    NTG
    PMA / PMN Number
    P160036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024, DT MEDTECH WAS MADE AWARE THAT A PATIENT UNDERWENT EMERGENCY SURGERY DUE TO THE EFFECTS OF INFECTION AND THE EXPLANT OF THE H3 DEVICE WAS SCHEDULED IMMEDIATELY THE NEXT DAY. THE DEVICE WAS EXPLANTED AND FOLLOWED THE APPROVED RETRIEVAL PROTOCOL. REVISION TREATMENT OF CEMENT SPACER WAS USED UNTIL INFECTION RESOLVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080305 HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT NTG DT MEDTECH LLC, A VILEX COMPANY 301204 AABWH

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention