BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALL SURGICAL

    MDR report key: 694034 · Received March 3, 2006

    Report

    Report Number
    MW1038261
    Event Type
    Injury
    Date Received
    March 3, 2006
    Date of Event
    September 30, 2003
    Report Date
    March 9, 2006
    Manufacturer
    LINVATEC CORPORATION
    Product Code
    HTT
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD AN ARTHROTOMY OF LEFT KNEE, POSSIBLE REMOVAL OF A CEMENTED REVISION TYPE OF STEMMED IMPLANT DONE IN 2003. DURING THE SURGERY A HIGH SPEED CUTTING BUR WAS USED FOR CUTTING THE BONE CEMENT INTERFACE OF THE FEMORAL COMPONENT. PT WAS TREATED BY THE SURGEON ON 11/15/2003 AND 3/13/2004 FOR PAIN AND SWELLING. PT WAS SEEN AT ANOTHER FACILITY. IN 2005, X-RAYS TAKEN DEMONSTRATED A RETAINED BALL TIPPED PIN OR PINEAPPLE BUR IN PT'S DISTAL TIBIAL SHAFT WITH CHANGES THAT WERE HIGHLY SUGGESTIVE OF LOCAL INFECTION. PT UNDERWENT SURGERY FOR REMOVAL OF HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALL SURGICAL OVAL BUR LONG CARBIDE HTT LINVATEC CORPORATION * BBB96756

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| S