BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL NECK SYSTEM

    MDR report key: 18064857 · Received November 1, 2023

    Report

    Report Number
    MW5147697
    Event Type
    Injury
    Date Received
    November 1, 2023
    Report Date
    October 27, 2023
    Manufacturer
    SYNTHES (USA), LLC.
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SYNTHES/JOHNSON AND JOHNSON "FEMORAL NECK SYSTEM". PATIENT HAD FEMORAL NECK FRACTURE, AND WENT ON TO NONUNION. THIS IS COMMON IN THIS AGE. HOWEVER, THE HARDWARE USED TO FIX THE FRACTURE BROKE IN TWO PLACES. ACCORDINGLY TWO BROKEN PIECES OF THE HARDWARE WERE LODGED IN THE HEAD AND HAD TO BE OVER DRILLED AND EXTRACTED TO ALLOW FOR REVISION OF THE NONUNION. WHILE IT IS CERTAINLY POSSIBLE FOR ANY HARDWARE TO FAIL UNDER FATIGUE IN THE FACE OF A NONUNION, THE NATURE OF THE FEMORAL NECK SYSTEM MADE EXTRACTION OF THE DEVICE VERY CHALLENGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333941 FEMORAL NECK SYSTEM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES (USA), LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention