BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HIP

    MDR report key: 1071418 · Received July 7, 2008

    Report

    Report Number
    9616680-2008-00191
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAD BEEN REQUESTED, AND IF IT BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT, "THAT SURGERY WAS PERFORMED BECAUSE THE IMPLANT BECAME LOOSE OUT OF THE JOINT, BECAUSE THE IMPLANT HAD EATEN A HOLE IN HER PELVIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HIP IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention