BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3003836 · Received March 14, 2013

    Report

    Report Number
    3005477969-2013-00076
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    June 13, 2012
    Report Date
    March 14, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    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 A POSSIBLE ADVERSE REACTION TO METAL DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107323 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 09EW23468

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R FEMORAL HEAD, PART # 74123144, LOT # 08HW18203