BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY LINER INSERTER - MECHANICAL

    MDR report key: 2060963 · Received March 14, 2011

    Report

    Report Number
    1822565-2011-00563
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    November 16, 2009
    Report Date
    November 24, 2009
    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 HANDLE HAS FRACTURED IN MULTIPLE LOCATIONS. ASIDE FROM THE FRACTURES, THE HANDLE (AND THE REMAINING PORTION OF THE DEVICE) EXHIBITS DAMAGE INDICATIVE OF NORMAL WEAR AND TEAR BROUGHT ON BY EXTENSIVE USE IN THE FIELD. THIS DAMAGE, AS WELL AS THE POTENTIAL FIELD AGE OF OVER 12 YEARS, INDICATES THAT NORMAL WEAR AND TEAR BROUGHT ON BY EXTENSIVE USE AND NUMEROUS STERILIZATION CYCLES IS THE CAUSE OF 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 OR 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 HANDLE BROKE WHILE IMPACTING THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY LINER INSERTER - MECHANICAL LXH ZIMMER, INC. 51617100

    Patients

    Seq Age Sex Outcome Treatment
    1