BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII, MODULAR STEM

    MDR report key: 2922107 · Received January 11, 2013

    Report

    Report Number
    9616680-2013-90102
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    K092406
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 ALTER. 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
    16375 ABGII, MODULAR STEM IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA G3013212

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention