BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING INSERTER

    MDR report key: 2080294 · Received March 31, 2011

    Report

    Report Number
    3005751028-2011-00027
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    February 2, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ZIMMER TMT
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERTER HOLDS THE IMPLANT AS INTENDED. VERIFIED INSERTER LOOSENS UPON IMPACTION. THERE IS NO VISIBLE DAMAGE TO THE INSERTER THOUGH IT LOOKS WORN. THE EXACT CAUSE FOR THE TM-500 IMPLANT INSERTER LOOSENING FROM THE IMPLANT UPON IMPACTION CANNOT BE DETERMINED, BUT IT IS LIKELY TO HAVE BEEN WORN DURING NORMAL USE. IT WAS FOUND THAT THE INSERTER HOLDS THE IMPLANT AS INTENDED. IF THIS ISSUE WERE TO REPEAT ITSELF, IT IS NOT EXPECTED TO CAUSE INJURY TO THE PT OR THE USER. IF LOOSENING OF THE INSERTER IS OBSERVED DURING INSERTION OF AN IMPLANT, THE INSERTER CAN BE TIGHTENED BETWEEN IMPACTIONS OR THE IMPLANT CAN BE INSERTED BY TAMPING IT IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERTER FAILED TO HOLD AND CONTROL THE TM-500 IMPLANTS. THERE WAS NO HARM REPORTED TO THE PT, BUT THE SURGICAL TIME WAS EXTENDED 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING INSERTER INSERTER LXH ZIMMER TMT 60763280

    Patients

    Seq Age Sex Outcome Treatment
    1