BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3842617 · Received June 2, 2014

    Report

    Report Number
    3005477969-2014-00349
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    October 23, 2013
    Report Date
    June 2, 2014
    Manufacturer
    SMITH & NEPHEW
    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. THE FEMORAL STEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320783 BHR ACETABULAR CUP NXT SMITH & NEPHEW 8597

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R MODULAR HEAD, # 74222144, LOT # 07EW11816| MODULAR SLEEVE, # 74222200, LOT # 07EW11883| FEMORAL STEM, # 71357106, LOT # 07CM02949