BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX STEMMED TIBIAL COMPONENT

    MDR report key: 5101388 · Received September 24, 2015

    Report

    Report Number
    1822565-2015-01965
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 31, 2015
    Report Date
    August 31, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    NJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIBIAL COMPONENT AND SET SCREW WERE RETURNED FOR REVIEW. INSPECTION OF THE TIBIAL PLATE IDENTIFIED NO VISIBLE SCRATCHES ON THE COLOR BUFFED SURFACE. MEASURED DIMENSIONS WERE CONFORMING TO PRINT SPECIFICATIONS. FUNCTIONAL TESTING IDENTIFIED THAT THE SET SCREW COULD BE FULLY THREADED INTO THE TIBIAL COMPONENT. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS RECEIVED FOR THIS PART AND LOT COMBINATION. THIS DEVICE IS USED FOR TREATMENT. THE ASSEMBLY INSTRUCTIONS FOR THE FLUTED MOBILE PLATES STATE THAT THE SET SCREW SHOULD BE INSERTED INTO THE HOLE ON THE POSTERIOR SIDE OF THE STEM AND ENGAGED 2.5 TO 3 COMPLETE TURNS PER THE PRINT SPECIFICATIONS. THE INSTRUCTIONS ALSO STATE THAT THE INSIDE TAPER OF THE STEM SHOULD BE CHECKED WITH A STEM EXTENSION TO ENSURE THE SET SCREW DOES NOT PROTRUDE INTO THE TAPER. IF THE SET SCREW INTERFERES WITH THE STEM EXTENSION, THE INSTRUCTIONS STATE THE SET SCREW SHOULD BE BACKED OUT UNTIL THERE IS NO INTERFERENCE. OPERATOR AWARENESS OF THIS COMPLAINT WAS PERFORMED AND REFRESHER TRAINING FOR ALL OPERATORS PACKAGING THIS DEVICE WAS COMPLETED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A LOCKING SCREW WAS SITTING LOOSELY IN THE PACKAGING. THE SCREW WAS SITTING ON THE POLISHED SURFACE OF THE COMPONENT WHICH LED TO SCRATCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633304 NEXGEN LPS-FLEX STEMMED TIBIAL COMPONENT NJL NJL ZIMMER INC 62273498

    Patients

    Seq Age Sex Outcome Treatment
    1