BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSET-US FULL DOSE 10 PK

    MDR report key: 3092108 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01507
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBB
    PMA / PMN Number
    K063857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A SIMPLEX PACKAGING WAS REPORTED. THE EVENT WAS NOT CONFIRMED AS THE REPORTED PRODUCT OR PHOTOGRAPHS WERE NOT PROVIDED. REVIEW OF THE BATCH MANUFACTURING RECORD INDICATES THAT THIS BATCH WAS MANUFACTURED AND SHIPPED TO STOCK WITH NO REPORTED DISCREPANCIES. REVIEW COMPLAINT HISTORY REVIEW DETERMINED THAT THERE WERE NO OTHER REPORTED EVENTS FOR THIS 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 ODOR 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 ODOR 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 AND THE ADDITIONAL INFORMATION PERTAINING TO THE DETAILS OF THE PACKAGING AND DAMAGE NOTED, IT APPEARS THAT THIS PRODUCT WAS DAMAGED DUE TO INAPPROPRIATE HANDLING OR STORAGE DURING DISTRIBUTION/TRANSPORTATION.

    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, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL RECEIVED BONE CEMENT THAT WAS DAMAGED ON ARRIVAL. THE VIALS WERE BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL RECEIVED BONE CEMENT THAT WAS DAMAGED ON ARRIVAL. THE VIALS WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194414 SPEEDSET-US FULL DOSE 10 PK IMPLANT MBB STRYKER ORTHOPAEDICS-MAHWAH DLT034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other