BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE STEM INSERTER/EXTRACTOR

    MDR report key: 1892802 · Received November 3, 2010

    Report

    Report Number
    2249697-2010-01456
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 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. THIS IS THE SAME PATIENT/EVENT AS MFR #9616680-2010-00704.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SURGEON PERFORMED A THA SURGERY ON THE PT (B)(4) 2010. THE SURGEON USED THE UNIVERSAL ACCOLADE TMZF STEM IMPACTOR TO INSERT THE ACCOLADE STEM INTO THE PATIENT'S FEMUR. HOWEVER, THE SURGEON COULD NOT COMPLETELY INSERT THE STEM. THEREFORE, HE TRIED TO REMOVE IT WITH THE ACCOLADE STEM INSERTER/EXTRACTOR. HOWEVER, HE COULD NOT COMBINE IT AND THE STEM. THEREFORE, HE REMOVED THE STEM BY USING HOSPITAL DEVICE AND IMPLANTED ANOTHER STEM((B)(4)) INSTEAD OF IT. THE SURGEON HAS THOUGHT THAT THE DRIVE HOLE WAS DEFORMED BY THE UNIVERSAL TMZF STEM IMPACTOR BECAUSE THE TIP OF THE IMPACTOR CONTACTED ON THE THREAD OF DRIVE HOLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE STEM INSERTER/EXTRACTOR INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention