BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1041173 · Received May 13, 2008

    Report

    Report Number
    3005477969-2008-00026
    Event Type
    Injury
    Date Received
    May 13, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 13, 2008
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD., U.K.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO FEMORAL COMPONENT LOOSENING AND AVASCULAR NECROSIS.

    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 50 YR Hospitalization| R (REMAINS IN SITU)| (REPLACEMENT FEMORAL HEAD)| LOT 26386| LOT UNKNOWN