BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HINTERMANN SERIES H3

    MDR report key: 25225061 · Received May 19, 2026

    Report

    Report Number
    3012104767-2026-00002
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 19, 2026
    Manufacturer
    DT MEDTECH, LLC
    Product Code
    NTG
    PMA / PMN Number
    P160036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT IMPLANTED WITH H3 DEVICES (B)(6) 2024 IN SWITZERLAND. PATIENT WAS EXPERIENCING PAIN BUT NO ISSUES COULD BE DETECTED DURING IMAGING MODALITIES. PATIENT UNDERWENT REVISION SURGERY IN SWITZERLAND (B)(6) 2026 AND WHILE REMOVING THE TALAR IMPLANT, IT WAS DISCOVERED THAT ONE OF THE PEGS HAD BROKEN. ALL IMPLANT COMPONENTS WERE REMOVED AND REPLACED WITH NEW H3 IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282977 HINTERMANN SERIES H3 TALAR IMPLANT, LEFT SIZE 3 NTG DT MEDTECH, LLC 302113 AABLY

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention