BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 2029491 · Received March 2, 2011

    Report

    Report Number
    1818910-2011-03373
    Event Type
    Other
    Date Received
    March 2, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    DEPUY CMW
    Product Code
    MBB
    PMA / PMN Number
    K081163
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET GMV 40G US EO 87MBB; 87LOD MBB DEPUY CMW NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention NA.