BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2921750 · Received January 18, 2013

    Report

    Report Number
    3005477969-2013-00026
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    May 10, 2012
    Report Date
    May 8, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY HAS BEEN PERFORMED DUE TO A SOFT TISSUE REACTION AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28445 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 93907 002

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R FEMORAL HEAD, PART#74121150, LOT # UNKNOWN