BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLER/GALANTE UNI TENSION GAUGE

    MDR report key: 3040295 · Received April 3, 2013

    Report

    Report Number
    1822565-2013-00582
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FRACTURES OF THIS TYPE ARE DUE TO REPEATED EXPOSURE TO LARGE BENDING FORCES. VISUAL EXAMINATION OF THE TENSION GAUGE CONFIRMS THAT THE DEVICE IS FRACTURED AND SHOWS WEAR AND SCRATCHES ON THE PORTION OF THE COMPONENT THAT FRACTURED OFF. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TENSION GAUGE WAS INSERTED INTO THE PT'S KNEE AND BROKE WHEN THE KNEE WAS FLEXED. THE TIP MIGRATED TO THE BACK OF THE KNEE, BUT WAS ABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136957 MILLER/GALANTE UNI TENSION GAUGE LXH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR