BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3844947 · Received June 3, 2014

    Report

    Report Number
    3005477969-2014-00353
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    April 22, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SMITH & NEPHEW
    Product Code
    NXT
    PMA / PMN Number
    P040033
    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 INCREASING PAIN, RAISED METAL IONS, SMALL FLUID COLLECTION, CLICKING OF HIP AND GROIN DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324114 BHR ACETABULAR CUP NXT SMITH & NEPHEW 09FW23647 020

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R FEMORAL HEAD, # (B)(4), LOT # 10BW25697 053