BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFIX

    MDR report key: 3973004 · Received July 29, 2014

    Report

    Report Number
    MW5037532
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    October 28, 2013
    Report Date
    July 24, 2014
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ASEPTIC LOOSENING WITHIN SIX MONTHS AFTER INSTALLATION SURGERY. NO INDICATION OF AN INFECTION. PROSTHESIS WAS MANUFACTURED BY SMITH AND NEPHEW AND THE MODEL NAME IS PROFIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441663 PROFIX PROFIX HSA SMITH AND NEPHEW

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R| S