BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 2063372 · Received February 18, 2011

    Report

    Report Number
    9610667-2011-00007
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 18, 2011
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    PMA / PMN Number
    081059
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TORNIER DEVICE COMPONENTS REPORTED INVOLVED ARE: FOUR UNITS OF SCREWS, 1 EACH, VDV229, VDV232, DWD023, DWD026. LOT NUMBERS NOT REPORTED. DATES OF MANUFACTURE AND STERILIZATION EXPIRY DATES WILL BE PROVIDED WITH DEVICE EVALUATION REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT ASSEMBLY DIFFICULTIES WERE ENCOUNTERED WITH THE COMPONENTS OF A TORNIER SHOULDER PROSTHESIS, SUCH THAT THE CENTRAL SECURING SCREW OF THE GLENOSPHERE WOULD NOT TURN/ENGAGE X2 WITH THE BASEPLATE COMPONENT. REMOVING THE GLENOSPHERE ON THE SECOND TIME CAUSED PULL OUT OF THE BASEPLATE AND FOUR BASEPLATE SCREWS. DAMAGE TO GLENOID REQUIRED BONE GRAFT USE AND CONVERSION OF SURGICAL PROCESS TO A HEMI-SHOULDER APPROACH. THE PT IS REPORTED IN SATISFACTORY AND STABLE CONDITION. THE ALTERNATE PROSTHESIS IMPLANTED IS REPORTED TO BE FREE OF ANY HARDWARE COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER PROSTHESIS, SHOULDER, SEMICONSTRAINED KWS TORNIER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention