BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO NRG INSERT TRIAL #9 8MM

    MDR report key: 3844170 · Received June 2, 2014

    Report

    Report Number
    0002249697-2014-02014
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCORPIO NRG PRIMARY KNEE AND INSTRUMENT BROKE. THE TIBIAL INSERT TRIAL CRACKED WHEN TRIED TO REMOVE FROM THE PATIENT. NO DELAY IN THE CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCORPIO NRG PRIMARY KNEE AND INSTRUMENT BROKE. THE TIBIAL INSERT TRIAL CRACKED WHEN TRIED TO REMOVE FROM THE PATIENT. NO DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322012 SCORPIO NRG INSERT TRIAL #9 8MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH SCHZA01NH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other