BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIOFLEX PS TIB INSERT

    MDR report key: 6063894 · Received October 28, 2016

    Report

    Report Number
    0002249697-2016-03390
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    October 3, 2016
    Report Date
    January 11, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K033971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO SUSPECTED WEAR OF A SCORPIO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. -DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES -COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE COULD BE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    PER SALES REP, THE ITEM WAS REMOVED DURING A RIGHT KNEE REVISION FOR SUSPECTED WEAR.

    Description of Event or Problem · 1

    PER SALES REP, THE ITEM WAS REMOVED DURING A RIGHT KNEE REVISION FOR SUSPECTED WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715739 SCORPIOFLEX PS TIB INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 13214901

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention