BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3151272 · Received June 7, 2013

    Report

    Report Number
    3005477969-2013-00228
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    June 5, 2013
    Report Date
    August 12, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INCREASING HIP PAIN AND DECREASING FUNCTIONAL CAPACITY OVER THE PAST 12 MONTHS. A SOFT TISSUE REACTION WAS REPORTEDLY NOTED ON AN ULTRASOUND. THE FEMORAL STEM REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252841 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 08CW16335

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R MODULAR HEAD, # 74222144, LOT # 9236| MODULAR SLEEVE # 74222200, LOT# 08CW16011| FEMORAL STEM, # 75002069, LOT # B0800073