BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2940446 · Received February 4, 2013

    Report

    Report Number
    3005477969-2013-00036
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    November 7, 2012
    Report Date
    February 4, 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 ELEVATED CHROMIUM AND COBALT LEVELS. DISCOMFORT, PAIN, AND CLICKING IN THE HIP REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45860 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FEMORAL HEAD, PART # AND LOT # UNKNOWN