BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG X3 CR TIBIAL INSERT #9 12MM

    MDR report key: 2202579 · Received August 8, 2011

    Report

    Report Number
    2249697-2011-01173
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K071991
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE OF THE HOSPITAL REPORTED TO OUR CLINICAL CONSULTANT THAT A X3 PS INLAY WAS BROKEN. THE PT CAME IN WITH PAIN AND A NOISE IN HIS KNEE. THEY DECIDE TO PERFORM A REVISION. DURING THIS THEY OBSERVED, THAT THE X3 PE INLAY WAS BROKEN. THEY REPLACED THE INLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO NRG X3 CR TIBIAL INSERT #9 12MM IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MHT43P

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention