BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPULSE SOLO

    MDR report key: 2943427 · Received January 8, 2013

    Report

    Report Number
    1213643-2013-00010
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FQH
    PMA / PMN Number
    K942886
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSP CONTACT CONFIRMED THAT THE PIECE WAS REMOVED WITHOUT ISSUE AND THERE WAS NO ADVERSE PT OUTCOME AS A RESULT OF THIS SITUATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND AT THIS TIME IT CANNOT BE DETERMINED HOW THE TIP CAME FREE. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON INFO REPORTED TO DAVOL: ON (B)(6) 2012, IT WAS ALLEGED THAT DURING A KNEE REVISION PROCEDURE, WHILE IRRIGATING WITH THE SIMPULSE, THE PLASTIC TIP WAS NOT GLUED ON AND CAME OFF DURING IRRIGATION AND WENT INTO THE FEMORAL CANAL. THE SURGEON NOTED THE FRAGMENT IN THE PT BEFORE THE CEMENTING PROCESS, PERFORMED FOLLOWING IRRIGATION, AND WAS ABLE TO RETRIEVE THE FRAGMENT FROM THE PT AND FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9609 SIMPULSE SOLO FQH DAVOL INC., SUB. C.R. BARD, INC. NA JUWIF302

    Patients

    Seq Age Sex Outcome Treatment
    1