BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG X3 PS TIBIAL INSERT #7 15MM

    MDR report key: 5769726 · Received July 5, 2016

    Report

    Report Number
    0002249697-2016-02179
    Event Type
    Injury
    Date Received
    July 5, 2016
    Date of Event
    January 3, 2016
    Report Date
    June 9, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K071991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED VIA CLINICAL OUTCOMES REPORTING STUDIES. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT MADE AVAILABLE 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. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION INVOLVING AN SCORPIO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND 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 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

    POSTOPERTIVE DIAGNOSIS: PATIENT HAD AN INDEX SURGERY OUTSIDE RI. ON (B)(6) 2015 DR. (B)(6) REVISED THE PATIENT FOR DJI WITH EXCHANGE OF THE POLY ONLY. THE PATIENT DEVELOPED NEW DJI, AND IS NOW REVISED WITH ALL COMPONENTS EXCHANGED.

    Description of Event or Problem · 1

    POSTOPERTIVE DIAGNOSIS: PATIENT HAD AN INDEX SURGERY OUTSIDE (B)(6). ON (B)(6) 2015 DR. (B)(6) REVISED THE PATIENT FOR DJI WITH EXCHANGE OF THE POLY ONLY. THE PATIENT DEVELOPED NEW DJI, AND IS NOW REVISED WITH ALL COMPONENTS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422730 SCORPIO NRG X3 PS TIBIAL INSERT #7 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH STRYKER ORTHOPAEDICS-MAHWAH MMK4PA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention