BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 1646444 · Received March 19, 2010

    Report

    Report Number
    9610667-2010-00004
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    February 1, 2010
    Report Date
    March 19, 2010
    Manufacturer
    TORNIER INC.
    Product Code
    KWS
    PMA / PMN Number
    K030941
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REFERENCE USER FACILITY REPORT (B)(4). IT IS REPORTED THAT DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY, THE STANDARD GLENOID SPHERE COMPONENT COULD NOT BE IMPACTED/ASSEMBLED TO THE CUSTOM BASEPLATE COMPONENT. A SECOND STANDARD GLENOID SPHERE COMPONENT WAS SELECTED AND ASSEMBLED WITHOUT FURTHER DIFFICULTY ENCOUNTERED. THE BASEPLATE REMAINS IMPLANTED. DEVICES INVOLVED ARE IDENTIFIED AS: SPHERE DWB 936, (B)(4) WOULD NOT SEAT TO CUSTOM BASEPLATE DXX002, (B)(4). THE SPHERE COMPONENT HAS BEEN RECOVERED FOR ANALYSIS. A STANDARD BASEPLATE DWD003, (B)(4) IS ADDITIONALLY NOTED IN THE UFR - THIS ITEM WAS CLINICALLY DETERMINED TO BE INCORRECT FOR PT ANATOMY - NO FAILURE OF THE DEVICE IS IDENTIFIED TO HAVE OCCURRED - WHERE THE CUSTOM BASEPLATE IDENTIFIED ABOVE WAS THEN EMPLOYED. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR