BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1140962 · Received August 28, 2008

    Report

    Report Number
    3005477969-2008-00053
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    November 29, 2007
    Report Date
    August 27, 2008
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD. UK
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R