BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 8115049 · Received November 29, 2018

    Report

    Report Number
    3003898228-2018-00020
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    August 23, 2018
    Report Date
    November 20, 2018
    Manufacturer
    FH INDUSTRIE
    Product Code
    KWS
    UDI-DI
    03661489651441
    PMA / PMN Number
    K112193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INTRAPROSTHETIC FRACTURE OF THE REVERSE ARROW PROTHESIS ( PLACED 10 YEARS OLD). MORSE TAPER FRACTURE ON HUMERAL STEM = DISLOCATION OF THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953870 ARROW ARROW STD HUMERAL INSERT D39 H00 KWS FH INDUSTRIE 03661489651441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention