BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL DEPTH GAUGE

    MDR report key: 2063145 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00711
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE DEPTH GAUGE TO DETERMINE APPROPRIATE LENGTH OF SCREWS, THE DEPTH GAUGE CONSISTENTLY GAVE READINGS THAT WERE 4MM LONGER THAN EXPECTED. THE IMPLANTED SCREWS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL DEPTH GAUGE LXH ZIMMER, INC. 41913000

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR