BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1221217 · Received November 5, 2008

    Report

    Report Number
    3005477969-2008-00077
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    August 25, 2008
    Report Date
    November 5, 2008
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD., U.K,
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED, DUE TO TRAUMA (MVA). THE IMPLANTING/REVISING SURGEON DOES NOT FAULT DEVICE AND STATES THERE WAS NO CLINICAL FAILURE OF THE DEVICE. PRIOR TO TRAUMA, THE PATIENT HAD A WELL FUNCTIONING HIP RESURFACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR RESURFACING FEMORAL HEAD KWY SMITH & NEPHEW ORTHOPAEDICS LTD., U.K, NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R ACETABULAR CUP