BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS EPOCH FULLCOAT FEMORAL STEM

    MDR report key: 2060970 · Received March 14, 2011

    Report

    Report Number
    1822565-2011-00571
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    November 3, 2009
    Report Date
    November 11, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SEVERAL JOB STEPS ARE IN PLACE TO ENSURE THAT THERE ARE NO LOOSE WIRES OR THAT PROTRUDING WIRES ARE BROKEN OFF AND GROUND DOWN. THE CAUSE OF THIS LOOSE WIRE CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 THIS 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 MESH PART OF THE EPOCH STEM HAS A WIRE STICKING OUT OF IT. WHEN IT WAS REMOVED FROM THE PACKAGING, THE WIRE PENETRATED BOTH SETS OF THE TECHNICIAN'S GLOVES. THIS COMPROMISED THE STERILITY OF THE IMPLANT SO IT COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS EPOCH FULLCOAT FEMORAL STEM LPH ZIMMER, INC. 60922237

    Patients

    Seq Age Sex Outcome Treatment
    1