BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION SPIKE ARM

    MDR report key: 2042215 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00555
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    November 19, 2009
    Report Date
    December 11, 2009
    Manufacturer
    ZIMMER INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICES WERE MANUFACTURED IN (B)(4) 2003 AND (B)(4) 2006, GIVING THEM POTENTIAL FIELD AGES OF APPROXIMATELY 6.25 AND 3 YEARS. THE IMPACTION/ EXTRACTION KNOBS ON THE SPIKE ARMS HAVE DAMAGE, INDICATING THAT THEY HAVE BEEN USED MANY TIMES; HOWEVER, THE NUMBER OF USES IS UNKNOWN. BECAUSE THE IMPACTION/EXTRACTION KNOB IS SLIGHTLY AWAY FROM THE LONGER SPIKE, IT IS POSSIBLE THAT OFF-AXIS IMPACTION, RESULTING IN A GREATER MOMENT ARM, MAY HAVE CONTRIBUTED TO THIS INCIDENT. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY FOR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE INSTRUMENTS WERE DAMAGED DURING NORMAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION SPIKE ARM LXH ZIMMER INC. 60082138

    Patients

    Seq Age Sex Outcome Treatment
    1 CATALOG #00599707300, LOT #60421280| NEXGEN COMPLETE KNEE SOLUTION SPIKE ARM