BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII MODULAR SHORT NECK

    MDR report key: 2922113 · Received January 11, 2013

    Report

    Report Number
    9616680-2013-90103
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
    Product Code
    KWY
    PMA / PMN Number
    K092406
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT NO OTHER INFO IS AVAILABLE DUE TO THE HOSPITAL'S POLICY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABGII STEM WAS REMOVED BECAUSE OF ALTR. THE STEM WAS REPLACED WITH A ZIMMER. THE LINER WAS REPLACED WITH A 36MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16331 ABGII MODULAR SHORT NECK IMPLANT KWY STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI NA G3029546

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R