BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    36MM +0(STD) V40 TRIAL HEAD

    MDR report key: 1905620 · Received November 12, 2010

    Report

    Report Number
    2249697-2010-01535
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "AFTER REDUCTION WITH THE TRIAL HEAD AND CENT PILLAR STEM, THE SURGEON COULD NOT DISSOCIATE IT FROM THE NECK OF A STEM. BECAUSE, IT WAS TOO TIGHT. THEREFORE, THE SURGEON WAS TRYING TO DISSOCIATE THE TRIAL HEAD WITH A HOSPITAL DEVICE AGAIN AND AGAIN. AS A RESULT, HE COULD DISSOCIATE IT FROM THE NECK OF A STEM, BUT THE STEM NECK WAS SCRATCHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 36MM +0(STD) V40 TRIAL HEAD INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA MHAV2L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention