BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3201619 · Received July 2, 2013

    Report

    Report Number
    3005477969-2013-00261
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 1, 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 FEMORAL NECK FRACTURE. THE DEVICE WAS ORIGINALLY IMPLANTED IN 2000. THE ACETABULAR CUP REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303218 BHR RESURFACING FEMORAL HEAD NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 5684 72

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R ACETABULAR CUP, PART AND LOT# UNKNOWN