BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREC FALC CARTG (19.5X1.33X105)

    MDR report key: 2041190 · Received March 29, 2011

    Report

    Report Number
    9616696-2011-00043
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE BLADE SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE ON THE TIBIAL CUT, THE CARTRIDGE BLADE BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE DID NOT FALL INTO THE SURGICAL SITE. IT WAS FURTHER REPORTED THAT A STEMMED FEMUR WAS USED INSTEAD OF THE INTENDED IMPLANT AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT A NEW BLADE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREC FALC CARTG (19.5X1.33X105) GFA STRYKER IRELAND LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention