BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MIX CEMVAC SYRINGE

    MDR report key: 2252595 · Received September 18, 2011

    Report

    Report Number
    1818910-2011-16543
    Event Type
    Malfunction
    Date Received
    September 18, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 23, 2011
    Manufacturer
    DEPUY WARSAW
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS RETURNED FOR INVESTIGATION. A LARGE AMOUNT OF POLYMERISED CEMENT WAS PRESENT IN THE BARREL ENDING AT THE TIP OF THE NOZZLE AND A SMALL AMOUNT OF CEMENT HAD ESCAPED PAST THE PISTON. THE MOST LIKELY ROOT CAUSE IS LATE EXTRUSION. NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME. DEPUY (B)(4) WILL CLOSELY MONITOR ANY COMPLAINTS OF THIS NATURE. A LARGE AMOUNT OF POLYMERISED CEMENT WAS PRESENT IN THE BARREL ENDING AT THE TIP OF THE NOZZLE AND A SMALL AMOUNT OF CEMENT HAD ESCAPED PAST THE PISTON. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    SYRINGE WAS BROKEN AND CEMENT LEAKED WHEN THE DOCTOR EXTRUDED CEMENT INTO THE FEMORAL CANAL. TIME OF SURGERY WAS EXTENDED BY 60 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART MIX CEMVAC SYRINGE CEMENT ACCESSORY LXH DEPUY WARSAW 10080084

    Patients

    Seq Age Sex Outcome Treatment
    1