BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO FIXD BPLATE PA SIZE 11

    MDR report key: 2191413 · Received July 28, 2011

    Report

    Report Number
    9610726-2011-00269
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    MBH
    PMA / PMN Number
    K033971
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN IMPACTING THE TIBIAL BASEPLATE, ONE OF THE PLASTIC LUGS THAT FITS IN THE SCREW HOLES HAS COME OUT. A SEARCH WAS MADE AND THE JOINT WAS WASHED OUT USING A PULSATILE LAVAGE. SURGEON EXPRESSED CONCERN ABOUT IT BEING IN THE JOINT SPACE AND THAT THIS HAS NOT OCCURRED BEFORE AND HE IS A LONG TIME USER OF SCORPIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO FIXD BPLATE PA SIZE 11 IMPLANT MBH STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other