BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3233577 · Received July 18, 2013

    Report

    Report Number
    3005477969-2013-00300
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 11, 2013
    Report Date
    July 18, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO FEMORAL HEAD LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334624 BHR FEMORAL HEAD NXT SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ACETABULAR CUP, PART AND LOT # UNKNOWN