BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER 52MM

    MDR report key: 1071421 · Received July 7, 2008

    Report

    Report Number
    9616680-2008-00187
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 18, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "IT'S LOOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL CLUSTER 52MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 19852801

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention