BEUDAMED
    FDA Adverse Event Summary report: N

    SMART SET MV

    MDR report key: 2539303 · Received April 5, 2012

    Report

    Report Number
    MW5025051
    Date Received
    April 5, 2012
    Date of Event
    October 21, 2010
    Manufacturer
    DEPUY
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010 - LEFT TOTAL KNEE ARTHROPLASTY FOR DJD OF LEFT KNEE. ON (B)(6) 2011 - LEFT KNEE REVISION TOTAL KNEE DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT OF THE TOTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART SET MV BONE CEMENT, 40G LOD DEPUY 3115021

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention