BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3960836 · Received July 28, 2014

    Report

    Report Number
    3005477969-2014-00428
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 9, 2014
    Report Date
    February 9, 2015
    Manufacturer
    SMITH & NEPHEW
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO AN ADVERSE REACTION TO METAL DEBRIS. THE DEVICES WERE IMPLANTED IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438258 BHR ACETABULAR CUP NXT SMITH & NEPHEW 7972

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FEMORAL HEAD, # (B)(4), LOT # NI