BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER 60MM

    MDR report key: 1760451 · Received July 13, 2010

    Report

    Report Number
    9616680-2010-00453
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 28, 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
    MN, 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. ADDITIONAL INFORMATION 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, "LARGE OSTEOLYSIS BEHIND SHELL. SURGEON REPLACED WITH A COMPETITIVE PRODUCT, AND 36MM C-TAPER HEAD IMPLANTS RETURNED TO PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL CLUSTER 60MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 12952001

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention