BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL

    MDR report key: 1160469 · Received September 12, 2008

    Report

    Report Number
    9616680-2008-00281
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE CUP WAS LOOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 20086501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention