BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL SOLID BK

    MDR report key: 1071420 · Received July 7, 2008

    Report

    Report Number
    9616680-2008-00189
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 19, 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
    NJ, 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SUBSEQUENTLY AFTER HIS PRIMARY HIP SURGERY, HE BEGAN TO EXPERIENCE A REOCCURRENCE OF INFECTIONS CAUSING HIM TO UNDERGO ADDITIONAL SURGERIES."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention