BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG X3 PS TIBIAL INSERT #3 12MM

    MDR report key: 2831054 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02133
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    January 1, 2011
    Report Date
    October 16, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K071991
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. DEVICES WERE RETAINED AT (B)(6) RESEARCH CENTER. MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO IRB RESTRICTION AT REPORTERS INSTITUTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 7115-0003, LOT # MJKEL DESCRIPTION: SERIES 7000 STANDARD TIBIA. CAT # 81-4405L LOT # MJR1VR DESCRIPTION: SCORPIO NRG PS FEMORAL #5 LEFT. CAT # UNK LOT # UNK DESCRIPTION: UNK PATELLAR POLYETHYLENE. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE COMPONENTS WERE IMPLANTED IN SITU FOR APPROXIMATELY 0.1 Y. THE FEMORAL, TIBIAL AND PATELLAR COMPONENTS WERE REVISED. THE PT PRESENTED WITH A UCLA SCORE OF 1 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUMS CORE OF 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO NRG X3 PS TIBIAL INSERT #3 12MM IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MKDL10

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention