BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART SET OMV BONE CEMENT 40G

    MDR report key: 2541443 · Received April 13, 2012

    Report

    Report Number
    MW5025071
    Event Type
    Injury
    Date Received
    April 13, 2012
    Date of Event
    October 29, 2009
    Manufacturer
    DEPUY
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009 - BILATERAL TOTAL KNEE ARTHROPLASTY FOR DJD OF BOTH KNEES. ON (B)(6) 2011 ,REVISION OF TIBIAL COMPONENT, RIGHT KNEE DUE TO LOOSE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART SET OMV BONE CEMENT 40G TOTAL KNEE ARTHROPLASTY LOD DEPUY 2946615

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention