BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO TS MOD TIB TRAY

    MDR report key: 1900895 · Received November 9, 2010

    Report

    Report Number
    2249697-2010-01511
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K994128
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING THE TKA, THE SURGEON WAS IMPLANTING THE SCORPIO TS BASE PLATE, A PE PLUG WAS SLIGHTLY POPPED OUT. THEREFORE, HE FILED THE TOP SURFACE OF THE PLUG BY HOSPITAL DEVICE AND IMPLANTED A PE INSERT WITHOUT ANY PROBLEMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO TS MOD TIB TRAY IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MHNMTP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other