BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3101296 · Received May 9, 2013

    Report

    Report Number
    3005477969-2013-00184
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 5, 2010
    Report Date
    July 23, 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

    Additional Manufacturer Narrative · 1

    THE IMPLANTATION OF A COMPETITOR FEMORAL STEM CONSTITUTES AN OFF LABEL APPLICATION OF THE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND ELEVATED METAL ION LEVELS. HIP AND GROIN PAIN BEGAN IN 2007, THOUGH X-RAYS INITIALLY SHOWED NO ISSUES. BY (B)(6) 2009 X-RAYS REPORTEDLY SHOWED AREAS OF LUCENCY AND ELEVATED METAL ION LEVELS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203548 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 26896

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R ZIMMER HIP STEM, SIZE 3, LOT # 60145123| MODULAR HEAD, PART # 74121546, LOT # 31747