BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2161147 · Received July 13, 2011

    Report

    Report Number
    3005477969-2011-00154
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    November 20, 2008
    Report Date
    February 15, 2012
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO OSTEOLYSIS IN NECK AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR RESURFACING FEMORAL HEAD NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 28143 074

    Patients

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