BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NKII MODULAR TIB OFFSET STEM TRIAL ADAPTER

    MDR report key: 1831971 · Received September 7, 2010

    Report

    Report Number
    1822565-2010-00664
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RETURNED, THE OFFSET STEM TRIAL ADAPTER SCREW IS WITHIN THE ADAPTER AND FLOATS FREELY AS DESIGNED. WHEN APPLYING PRESSURE TO TURN THE SCREW WITH A HEX DRIVER, IRREGULARITIES BETWEEN THE MATING SURFACES OF THE SCREW AND ADAPTER CAN BE FELT. IN GENERAL, THESE IRREGULARITIES COULD BE ATTRIBUTED TO, BUT IS NOT LIMITED TO, DEFORMATION FROM EXCESSIVE FORCE APPLICATION, OFF-AXIS FORCE APPLICATION, OR MATERIAL WEAR; HOWEVER, WITH THE AVAILABLE INFORMATION, THE ROOT CAUSE FOR SCREW SEPARATION CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. THE PRODUCT WAS RETURNED FOR EVALUATION. THE PROVISIONAL INSTRUMENT HAS BEEN IN THE FIELD FOR APPROXIMATELY 4.5 YEARS; HOWEVER, ACTUAL USAGE OF THE INSTRUMENT IS UNKNOWN. THERE IS SUPERFICIAL SCRATCHING ON THE OUTER SURFACE NEAR THE PROXIMAL END.

    Description of Event or Problem · 1

    IT IS REPORTED THAT SURGERY WAS DELAYED FOR 1 HOUR WHEN THE FLOATING SCREW CAME OUT OF THE OFFSET INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NKII MODULAR TIB OFFSET STEM TRIAL ADAPTER KNEE INSTRUMENT LXH ZIMMER INC. 60423507

    Patients

    Seq Age Sex Outcome Treatment
    1