BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL SIMPLEX CEMENT

    MDR report key: 2974067 · Received February 22, 2013

    Report

    Report Number
    0002249697-2013-00755
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE RETURNED UNIT CARTON APPEARS TO HAVE BEEN SUBJECTED TO COMPRESSION AND EXCESSIVE HANDLING. THE UNDERSIDE OF THE UNIT CARTON HAS SOME SLIGHT STAINING WHICH MAY BE AS A RESULT OF INK TRANSFER FROM A DAMP ADJOINING UNIT CARTON WITHIN THE 10 PACK. THE TYVEK LID OF THE AMPOULE BLISTER HAS BEEN FULLY DETACHED FROM THE BLISTER. IT APPEARS THAT THE ADHESIVE HAS BEEN DISSOLVED FROM THE BLISTER, MOST LIKELY AS A RESULT OF CONTACT WITH MONOMER. THERE ARE INDICATIONS THAT THE LID HAD ORIGINALLY ADHERED TO THE BLISTER FLANGE. THERE IS ALSO STAINING PRESENT ON THE LID AND WRINKLING OF THE TYVEK WHICH IS INDICATIVE OF THE EFFECTS OF MONOMER ON THE MATERIAL. THE AMPOULE ITSELF IS NOT DAMAGED, HOWEVER IT IS REPORTED THAT IN THE SECOND UNIT THE BOTTLE OF THE BONE CEMENT MONOMER WAS CRACKED OPEN IN THE SEALED PACKAGING. THE EVENT WAS CONFIRMED. THE INVESTIGATION CONCLUDED THAT THE UNSEALED AMPOULE BLISTER PACK WAS MOST LIKELY CAUSED BY LEAKING MONOMER FROM AN ADJACENT UNIT CARTON. IT IS KNOWN THAT LEAKING MONOMER DISSOLVES THE ADHESIVE PRESENT BETWEEN THE TYVEK LID AND THE BLISTER. IT WAS ALSO NOTED THAT THE UNIT CARTON APPEARS TO HAVE BEEN SUBJECTED TO EXCESSIVE HANDLING. THIS EXCESSIVE HANDLING MAY HAVE CAUSED THE AMPOULE OF THE ADJACENT UNIT CARTON TO CRACK WHEREBY MONOMER LEAKED OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIQUID WAS NOT SEALED PROPERLY IN THE PLASTIC PACKAGING COMPROMISING STERILITY. IT WAS ADDITIONALLY REPORTED THAT THE SECOND BOTTLE OF BONE CEMENT MONOMER WAS CRACKED OPEN IN THE SEALED PACKAGING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIQUID WAS NOT SEALED PROPERLY IN THE PLASTIC PACKAGING COMPROMISING STERILITY. IT WAS ADDITIONALLY REPORTED THAT THE SECOND BOTTLE OF BONE CEMENT MONOMER WAS CRACKED OPEN IN THE SEALED PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77802 SURGICAL SIMPLEX CEMENT IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH CDT049

    Patients

    Seq Age Sex Outcome Treatment
    1 Other