BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2892070 · Received January 2, 2013

    Report

    Report Number
    3005477969-2013-00001
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    June 14, 2012
    Report Date
    April 11, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO ELEVATED METAL IONS IN SERUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 77447 020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FEMORAL HEAD: PART# (B)(4), LOT# 74046