BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL

    MDR report key: 1915727 · Received November 29, 2010

    Report

    Report Number
    9616680-2010-00775
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    January 29, 2007
    Report Date
    November 12, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT STATED NOT LONG AFTER HER HIP REPLACEMENT, SHE STARTED EXPERIENCING AN ON AND OFF PAIN IN HER GROIN WHICH IS NOW A CONSTANT THING. SHE ALSO EXPERIENCES A PAIN DOWN HER LEG. SHE CAN'T LIFT HER LEG, NOR BEND AND HAS TROUBLE TYING HER SHOES. PT DID CONSULT WITH HER SURGEON; X-RAYS WERE TAKEN AND EVERYTHING LOOKED TO BE IN PLACE. HE GAVE HER PAIN MEDICATION AND ALSO SENT HER TO PAIN MANAGEMENT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other