BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3133666 · Received May 29, 2013

    Report

    Report Number
    3005477969-2013-00217
    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

    Description of Event or Problem · 1

    IT WAS REPORT THAT REVISION SURGERY WAS PERFORMED IN (B)(6) 2011 DUE TO PAIN, RESTRICTED MOBILITY AND INCREASED LEVELS OF COBALT AND CHROMIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234241 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 085898

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R FEMORAL HEAD, PART # 74121142, LOT # 50786