BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PKR INSERT X3 #5 RM/LL -8MM

    MDR report key: 3940634 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02752
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    PMA / PMN Number
    K082567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    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. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSPECTION THE INSERT AND OUTSIDE SEAL WAS INTACT BUT INSIDE PACKAGING SEAL WAS BROKEN, IT WAS LOOSE INSIDE THE OUTER PACKAGING. WE OPENED ANOTHER INSERT TO INSURE STERILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSPECTION THE INSERT AND OUTSIDE SEAL WAS INTACT BUT INSIDE PACKAGING SEAL WAS BROKEN, IT WAS LOOSE INSIDE THE OUTER PACKAGING. WE OPENED ANOTHER INSERT TO INSURE STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419894 TRIATHLON PKR INSERT X3 #5 RM/LL -8MM IMPLANT NPJ STRYKER ORTHOPAEDICS-MAHWAH MNH6HJ

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other