BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STD, LT HUMERAL ASSEMBLY

    MDR report key: 1210286 · Received October 21, 2008

    Report

    Report Number
    2249697-2008-00326
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSD
    PMA / PMN Number
    K980502
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED, AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD THE DEVICE BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DISASSOCIATED AFTER 3 YEARS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STD, LT HUMERAL ASSEMBLY IMPLANT HSD STRYKER ORTHOPAEDICS MAHWAH NA 32734901

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention