BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO NRG INSERT TRIAL #7 10MM

    MDR report key: 2191439 · Received July 28, 2011

    Report

    Report Number
    2249697-2011-01136
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME PT/EVENT AS MFR# 2249697-2011-01135. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SURGEON TRIED PLACING THE INSERTS ONTO THE TIBIAL BASEPLATE IMPLANT AND COULD NOT GET IT TO SEAT PROPERLY. HE USED THE TIBIAL INSERT IMPACTOR AND ONE TRIAL CRACKED AND THE OTHER TRIAL BROKE IN HALF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO NRG INSERT TRIAL #7 10MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other