BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSETMV MV ENDURANCE 40 G

    MDR report key: 1923886 · Received December 8, 2010

    Report

    Report Number
    1818910-2010-09399
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    P960001/S005
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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 LOOSENING OF THE STEM AT THE CEMENT/BONE INTERFACE. DEPUY CEMENT WAS USED IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSETMV MV ENDURANCE 40 G 87LOD LOD DEPUY CMW NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention