BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG X3 CR TIBIAL INSERT #5 15MM

    MDR report key: 2221279 · Received August 17, 2011

    Report

    Report Number
    2249697-2011-01204
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORDS & COMPLAINT HISTORY. AN EVALUATION OF THE DEVICES CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED BUT NOT MADE AVAILABLE. THE RESULTS OF THE INVESTIGATION INDICATE THAT THERE IS NO EVIDENCE OF PROSTHETIC DESIGN, MANUFACTURING, STERILIZATION, OR MATERIAL FACTORS RESPONSIBLE FOR THE REPORTED EVENT. BASED ON THE PROVIDED INFORMATION, IT IS MOST LIKELY THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER PATIENT OR CLINICAL FACTOR RELATED. THE DEVICE HISTORY REVIEW FOR REPORTED LOT OF DEVICES INDICATES THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO STOCK WITH NO REPORTED INCIDENTS. REVIEW OF THE STERILIZATION RECORD SHOWS THAT THIS STERILE LOT HAS BEEN CERTIFIED AND RELEASED AS STERILE FINISHED PRODUCT IN (B)(6) 2008. THERE HAVE BEEN NO OTHER REPORTED EVENTS FOR THE REPORTED LOT MEPMAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT HAD AN INFECTION. THE SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT AND REPLACED THE INSERT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO NRG X3 CR TIBIAL INSERT #5 15MM IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MEPMAR

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention