BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX P FULL DOSE 1 PACK

    MDR report key: 1873596 · Received October 12, 2010

    Report

    Report Number
    9610726-2010-00348
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    April 19, 2010
    Report Date
    September 20, 2010
    Manufacturer
    STRYKER ORTHOPAEDCIS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    N17004
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR.#9610726-2010-00349.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PT UNDERWENT LEFT TOTAL ELBOW ARTHROPLASTY IN LATE SPRING OF 2010. DURING THE PROCEDURE, A TOTAL OF EIGHT BATCHES OF CEMENT WERE USED ON THE PT. THE CEMENT WAS INSERTED INTO THE HUMERAL CANAL WITH THE GUN AT APPROXIMATELY FOUR MINUTES AFTER MIXING THE CEMENT. THE SURGEON DICTATED THERE WAS PREMATURE HARDENING OF THE SIMPLEX CEMENT, WHICH REQUESTED A HUMERAL OSTEOTOMY TO REMOVE THE INADEQUATELY SEATED HUMERAL PROSTHESIS. TWO OUT OF THE EIGHT BATCHES WERE IN QUESTION AND BOTH WERE FROM DIFFERENT LOT NUMBERS. THESE WERE NO ADDITIONAL PROBLEMS REPORTED ON CASES FROM THESE TWO LOTS. PROCEDURE WAS LEFT TOTAL ELBOW ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P FULL DOSE 1 PACK IMPLANT LOD STRYKER ORTHOPAEDCIS LIMERICK NA RJQ196

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention