BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 5 X 12MM SCORPIO PS INSERT

    MDR report key: 2150618 · Received June 23, 2011

    Report

    Report Number
    2249697-2011-00951
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME PT/EVENT AS MFR # 2249697-2011-00952.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, 'SURGEON REMOVED THE SCORPIO PS INSERT IN WHICH THE MARKINGS APPEARED TO INDICATE A 3 X 12MM. THE SURGEON' THEREFORE, ATTEMPTED TO IMPLANT A 3 X 15MM INTENDING TO UPSIZE AND FOUND THE INSERT TO BE TOO SMALL. THE SURGEON THEN IMPLANTED A 5 X 15MM SCORPIO PS INSERT WHICH LOCKED IN PERFECTLY. THE SURGEON, SALES REP AND SURGICAL STAFF ALL BELIEVE THE MARKINGS ON THE EXPLANTED TRIAL TO READ 3 X 12MM. THEY ARE UNSURE IF THE MARKINGS WERE SOMEHOW SKEWED OR INITIALLY MARKED INCORRECTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN 5 X 12MM SCORPIO PS INSERT IMPLANT HSH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention