BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HINTERMANN SERIES H3 TOTAL ANKLE - TALAR COMPONENT

    MDR report key: 12263731 · Received August 2, 2021

    Report

    Report Number
    3012104767-2021-00002
    Event Type
    Injury
    Date Received
    August 2, 2021
    Date of Event
    July 8, 2021
    Report Date
    August 3, 2021
    Manufacturer
    DT MEDTECH LLC
    Product Code
    NTG
    UDI-DI
    B0953011131
    PMA / PMN Number
    P160036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    PATIENT ANKLE JOINT REVISION DUE TO MALALIGNMENT. REVISED DUE TO PATIENT CIRCUMSTANCE OF SEVERE FLATFOOT AND PLES PLANUS VALGUS DUE TO TENDON LAXITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161002 HINTERMANN SERIES H3 TOTAL ANKLE - TALAR COMPONENT COATED TALAR COMPONENT NTG DT MEDTECH LLC 301113 AAAKO B0953011131

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention