BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 2071612 · Received April 20, 2011

    Report

    Report Number
    9616680-2011-00236
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 5, 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
    VA, 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 INFO PERTAINING TO THE EVENT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA 20521701

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention