BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL

    MDR report key: 1012652 · Received March 11, 2008

    Report

    Report Number
    9616680-2008-00062
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MRA
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT VISITED DR'S OFFICE DUE TO HIP PAINS. PATIENT HAD COMPLAINED OF PAIN SINCE ORIGINAL SURGERY OF 2005. DURING REVISION SURGERY, IT WAS NOTED THAT THE CUP WAS GROSSLY LOOSE AND THE TRUNNION WAS IMPINGING ON THE ALUMINA INSERT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA 15253401

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention