BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.E. ZIMMER

    MDR report key: 2941012 · Received October 10, 2006

    Report

    Report Number
    2941012
    Event Type
    Malfunction
    Date Received
    October 10, 2006
    Date of Event
    September 28, 2006
    Report Date
    October 9, 2006
    Manufacturer
    ZIMMER - RANDALL ASSOCIATES
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEFT TOTAL KNEE ARTHROPLASTY PERFORMED ON (B)(6) 2006. ON (B)(6) 2006 ZIMMER REP WHO RE-ASSEMBLING THE TOTAL JOINT INSTRUMENT TRAY NOTICED THREE DEGREE EXTERNAL ROTATION GUIDE WAS NOT INTACT. THE 6-INCH METAL SIZING GUIDE ROD HAD BROKEN OFF. POST-OP X-RAYS WERE REVIEWED TO FIND THE METAL ROD WAS RETAINED IN THE LEFT TOTAL LEMUR CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.E. ZIMMER THREE DEGREE EXTERNAL ROTATION GUIDE LXH ZIMMER - RANDALL ASSOCIATES 5978-03

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR