BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3932863 · Received July 14, 2014

    Report

    Report Number
    3005477969-2014-00393
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 28, 2014
    Report Date
    March 2, 2015
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BONE LOSS AND DEVICE LOOSENING REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO FAILURE OF THE DEVICES. THE TYPE OF FAILURE WAS NOT REPORTED. IMPLANTATION WAS IN (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410942 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 73864

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R FEMORAL HEAD, # (B)(4), LOT # 84003| FEMORAL HEAD, PART AND LOT NUMBERS UNKNOWN