BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1032909 · Received April 23, 2008

    Report

    Report Number
    3005477969-2008-00024
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 23, 2008
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD. U.K.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO CHRONIC PAIN. THE ACETABULAR AND FEMORAL IMPLANTS WERE REPORTED TO BE WELL FIXED.

    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 Hospitalization| R BHR ACETABULAR CUP EXACT PART AND LOT #S UNK