BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HINTERMANN SERIES H3

    MDR report key: 24959628 · Received April 22, 2026

    Report

    Report Number
    3012104767-2026-00001
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 22, 2026
    Manufacturer
    DT MEDTECH, LLC
    Product Code
    NTG
    PMA / PMN Number
    P160036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DURING AN H3 TOTAL ANKLE REPLACEMENT PROCEDURE, THE TALAR IMPLANT BOX WAS OPENED FOR A SIZE 2 LEFT TALAR IMPLANT BUT THE PART INSIDE THE BOX WAS A SIZE 2 RIGHT TALAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258246 HINTERMANN SERIES H3 TALAR IMPLANT NTG DT MEDTECH, LLC 302112 AACAA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown