BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW

    MDR report key: 7058448 · Received November 27, 2017

    Report

    Report Number
    3003898228-2017-00011
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    September 26, 2017
    Report Date
    November 21, 2017
    Manufacturer
    FH INDUSTRIE
    Product Code
    KWS
    UDI-DI
    03661489570605
    PMA / PMN Number
    K112193
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BREAK OF THE HUMERAL INSERT ARROW. REVERSE PROSTHESIS IN 2014. THE PATIENT FELT HIS SHOULDER GO WHILST LIFTING SHOPPING IN CAR. WHEN THE SURGEON WENT IN, THE GLENOID SPHERE WAS SOLID ALTHOUGH THE SURGEON DOES NOTE THAT THE POSITION WASN'T PERFECT. LIKEWISE THE STEM WAS ALSO FIRMLY IN PLACE. THE METAL STUMP OF GLENOID BASE HAD SHEARED OFF AND HAD DISPLACED. THE SURGEON REMOVED STEM WITH THE STUMP IN PLACED AND FITTED A NEW ONE WITH METAL BACK GLENOID BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839971 ARROW INSERT HUMERAL METAL-BACK ARROW DIAM 39 H00 KWS FH INDUSTRIE D00729 03661489570605

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention