BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL SOLID BACK SHELL

    MDR report key: 1760420 · Received July 13, 2010

    Report

    Report Number
    9616680-2010-00465
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 5, 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
    AS
    Reporter Occupation
    UNKNOWN

    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

    POSSIBLE DEVICE RELATED COMPLICATION REPORTED DURING CLINICAL TRIAL. PATIENT EXPERIENCED "GRINDING" SENSATION ON FULL FLEXION/INTERNAL ROTATION. PATIENT IS HYPERMOBILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL SOLID BACK SHELL IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 20316201

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other