BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - US HALF DOSE 10-PK

    MDR report key: 4221333 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04096
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K062553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER PROVIDED (RHV083) IS INVALID. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DISPOSED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A SIMPLEX PACKAGING WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THERE WAS NO PATIENT INVOLVEMENT. DEVICE HISTORY REVIEW: REVIEW OF THE BATCH MANUFACTURING RECORD INDICATES THAT THIS BATCH WAS MANUFACTURED AND SHIPPED TO STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW DETERMINED THAT THERE WERE NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT. CONCLUSIONS: THE EVENT WAS NOT CONFIRMED AS NO DEVICES OR PHOTOGRAPHS WERE 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL NOTICED A SMELL COMING FROM BOX AND BONE CEMENT BOX LEAKING WHEN THEY SIGNED FOR ORDER. THEY HAD FED EX NOTE. THE HOSPITAL IMMEDIATELY HAD BONE CEMENT DISPOSED OF ACCORDING TO PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL NOTICED A SMELL COMING FROM BOX AND BONE CEMENT BOX LEAKING WHEN THEY SIGNED FOR ORDER. THEY HAD FED EX NOTE. THE HOSPITAL IMMEDIATELY HAD BONE CEMENT DISPOSED OF ACCORDING TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701143 SIMPLEX P - US HALF DOSE 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH RHV083

    Patients

    Seq Age Sex Outcome Treatment
    1 Other