BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROVEN KNEE INSTRUMENT

    MDR report key: 247904 · Received October 29, 1999

    Report

    Report Number
    2530191-1999-00001
    Event Type
    Other
    Date Received
    October 29, 1999
    Date of Event
    October 13, 1999
    Report Date
    October 27, 1999
    Manufacturer
    STELKAST CO.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FEMORAL INSERTER INSTRUMENT BROKE DURING IMPLANT OF A FEMORAL KNEE COMPONENT WHEN THE SURGEON WAS POUNDING ON THE INSTRUMENT. THE BROKEN INSTRUMENT WAS IMMEDIATELY DETECTED BY THE SURGEON. HOWEVER, IT WAS NOT NOTICED THAT A SMALL BROKEN PIECE HAD FALLEN INTO THE WOUND UNTIL POST-OPERATIVE X-RAYS. THE PT WAS IMMEDIATELY RETURNED TO THE OPERATION ROOM, AND THE PIECE WAS REMOVED. NORMAL RECOVERY THEN OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVEN KNEE INSTRUMENT FEMORAL INSERTER/EXTRACTOR LXH STELKAST CO. SC1886 980194

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other