BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/G UNICOMPARTMENTAL TENSION GAUGE

    MDR report key: 1915708 · Received December 1, 2010

    Report

    Report Number
    1822565-2010-01246
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE TENSION GAUGE IT FRACTURED. A PORTION OF THE GAUGE COULD NOT BE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M/G UNICOMPARTMENTAL TENSION GAUGE KNEE INSTRUMENT LXH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1