BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV GENTAMICIN 40G

    MDR report key: 1410014 · Received July 2, 2009

    Report

    Report Number
    1818910-2009-03306
    Event Type
    Injury
    Date Received
    July 2, 2009
    Date of Event
    June 2, 2009
    Report Date
    June 2, 2009
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    K033382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LUCENCY AROUND THE FEMORAL AND TIBIAL DEVICES LIKELY BECAUSE THE CEMENT DID NOT INTERDIGITATE INTO SCLEROTIC BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET GMV GENTAMICIN 40G 87LOD LOD DEPUY CMW NA 2354780

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention