BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 2042101 · Received March 30, 2011

    Report

    Report Number
    9616680-2011-00155
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ALUMINA INSERT WAS COMPLETELY BROKEN OUT OF THE TITANIUM SHELL IN A LOT OF PIECES. NO KNOWN TRAUMA REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA 19324901

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention