BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2830975 · Received November 14, 2012

    Report

    Report Number
    3005477969-2012-00378
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    February 23, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD 22500 006

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R FEMORAL HEAD, PART #74121146, LOT #24285 045