BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMTEC CERAMIC INS/SLEEVE TRIDENT E

    MDR report key: 1080429 · Received July 21, 2008

    Report

    Report Number
    9616680-2008-00211
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MRA
    PMA / PMN Number
    P0000013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ALUMINIUM CERAMIC LINER FRACTURED. REVISION SURGERY REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERAMTEC CERAMIC INS/SLEEVE TRIDENT E IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA 10118355CG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention