BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3132736 · Received May 29, 2013

    Report

    Report Number
    3005477969-2013-00216
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    August 14, 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 COMBINATION OF PARTS IMPLANTED IN THIS CASE CONSTITUTES AN OFF-LABEL APPLICATION OF THE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED IN (B)(6) 2012 DUE TO PAIN AND ELEVATED CHROMIUM AND COBALT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234941 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 50059

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R DE PUY CORAIL FEMORAL STEM, UNKNOWN PART NO.| MODULAR HEAD, PART # 121354, LOT # 33955