BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2182926 · Received July 28, 2011

    Report

    Report Number
    3005477969-2011-00163
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 19, 2011
    Report Date
    September 20, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND ELEVATED COBALT LEVELS. AT TIME THE TIME OF REVISION SURGERY THERE WAS INCREASED FLUID AND INFLAMMATORY TISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR RESURFACING FEMORAL HEAD NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 51838

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R ACETABULAR CUP, PART#74121150, LOT# 53122