BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOP

    MDR report key: 7984875 · Received October 19, 2018

    Report

    Report Number
    3003898228-2018-00016
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    February 6, 2018
    Report Date
    October 11, 2018
    Manufacturer
    FH INDUSTRIE
    Product Code
    LXH
    UDI-DI
    03661489108747
    PMA / PMN Number
    D114497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE INSERTION OF A HIP PROSTHESIS, THE TIP OF THE ESOP FEMORAL SIZER BROKE IN THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825026 ESOP ESOP FEMORAL SIZER LXH FH INDUSTRIE N690448 03661489108747

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other