BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 3223558 · Received July 12, 2013

    Report

    Report Number
    0002249697-2013-02273
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    FDANA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. VISUAL INSPECTION CONFIRMED THAT THE FOREIGN MATERIAL IS A PIECE OF GLASS. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION CONCLUDED THAT FOREIGN MATERIAL IS A PIECE OF GLASS. INSTRUCTIONS ARE PROVIDED IN THE IFU; DO NOT OPEN THE AMPOULE OVER THE MIXING CONTAINER. PIECES OF GLASS MAY FALL INTO THE CONTAINER AND GET INTERMIXED WITH THE BONE CEMENT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. THE REPORTED EVENT REGARDING A FOREIGN MATERIAL IN THE CEMENT MIX INVOLVING SIMPLEX P BONE CEMENT WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOREIGN MATERIAL WAS NOTICED IN THE BOWL WHEN THE SURGEON STARTED TO MIXED IT. SO, THE SURGEON STOPPED TO USE THE CEMENT AND SPARE PRODUCT WAS USED INSTEAD OF IT. IT IS POSSIBILITY THAT THE FOREIGN MATERIAL IS A GLASS OF THE MONOMER AMPOULE. THE SURGEON REQUEST US THE MATERIAL ANALYSIS AND RISK FOR THE PATIENT IF THE MATERIAL WAS IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOREIGN MATERIAL WAS NOTICED IN THE BOWL WHEN THE SURGEON STARTED TO MIXED IT. SO, THE SURGEON STOPPED TO USE THE CEMENT AND SPARE PRODUCT WAS USED INSTEAD OF IT. IT IS POSSIBILITY THAT THE FOREIGN MATERIAL IS A GLASS OF THE MONOMER AMPOULE. THE SURGEON REQUEST US THE MATERIAL ANALYSIS AND RISK FOR THE PATIENT IF THE MATERIAL WAS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323468 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH JBU005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other