BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3802297 · Received May 9, 2014

    Report

    Report Number
    3005477969-2014-00313
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    June 27, 2013
    Report Date
    May 9, 2014
    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

    Additional Manufacturer Narrative · 1

    THE ABOVE COMBINATION OF DEVICES CONSTITUTES AN OFF LABEL APPLICATION IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE FAILURE OF THE IMPLANTS. THE TYPE OF FAILURE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280972 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HEMI HEAD, PART AND LOT NUMBERS UNKNOWN