BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSET-US FULL DOSE 10 PK

    MDR report key: 3898248 · Received June 26, 2014

    Report

    Report Number
    0002249697-2014-02467
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBB
    PMA / PMN Number
    K063857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED DUE TO THE ODOR.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A SIMPLEX UNIT CARTON WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW OF THE BATCH MANUFACTURING RECORD INDICATES THAT THIS BATCH WAS MANUFACTURED AND SHIPPED TO STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW DETERMINED THAT THERE WERE NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT. THE EVENT WAS NOT CONFIRMED AS THE REPORTED PRODUCT OR PHOTOGRAPHS WERE NOT PROVIDED FOR REVIEW. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS AN ODOUR COMING FROM THE PRODUCT WHEN THE REPORTED DAMAGE WAS NOTED. THIS INDICATES THAT AN AMPOULE(S) WAS BROKEN AT THE TIME OR SHORTLY BEFORE THE PRODUCT WAS RECEIVED BY THE CUSTOMER AS THE SMELL WOULD HAVE COME FROM THE MONOMER WHEN THE AMPOULE WAS BROKEN. THIS ODOUR FROM THE MONOMER LIQUID LASTS A SHORT PERIOD OF TIME AS THE LIQUID EVAPORATES WHEN EXPOSED TO THE ATMOSPHERE. BASED ON THE DESCRIPTION OF THE EVENT, IT APPEARS THAT THIS PRODUCT WAS DAMAGED DUE TO INAPPROPRIATE HANDLING OR STORAGE DURING DISTRIBUTION/TRANSPORTATION. NCR (B)(4) WAS RAISED IN JANUARY 2010 TO ADDRESS A TREND NOTED FOR DAMAGE TO SIMPLEX PACKAGING. THIS TREND WAS BASED ON THE VOLUME OF COMPLAINTS RECEIVED ASSOCIATED WITH PACKAGING DAMAGE FOR SIMPLEX PRODUCT. UPON APPLICATION OF ADVERSE TREND DETECTION IT WAS DETERMINED THAT THE RATE IS WITHIN THE RISK ACCEPTABILITY CRITERIA. PACKAGE DESIGN REVIEW WAS CARRIED OUT AS PART OF THE NCR AND IT WAS DETERMINED THAT FURTHER DESIGN REVIEW WILL BE COMPLETED UNDER PACKAGING INNOVATION QUALITY IMPROVEMENT PROJECTS. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME AS NO PRODUCT AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DAMAGED CASE OF SPEEDSET CEMENT REC'D CAT 6192-1-010, LOT DLU033.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DAMAGED CASE OF SPEEDSET CEMENT REC'D CAT 6192-1-010 LOT DLU033.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375082 SPEEDSET-US FULL DOSE 10 PK IMPLANT MBB STRYKER ORTHOPAEDICS-MAHWAH DLU033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other