BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1221220 · Received November 5, 2008

    Report

    Report Number
    3005477969-2008-00080
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 1, 2007
    Report Date
    November 5, 2008
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD. U.K.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED 5 YEARS POST-OP DUE TO INCREASING PAIN AND RESTRICTED RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP KWB SMITH & NEPHEW ORTHOPAEDICS LTD. U.K. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R REVISED TO CERAMIC ON CERAMIC STEMMED| PROSTHESIS| FEMORAL HEAD