BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE 5.5 PLUS

    MDR report key: 1190443 · Received October 2, 2008

    Report

    Report Number
    9616680-2008-00310
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 26, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS 3/4 OF AN INCH PROUD AND WOULD NOT SEAT IN THE METAPHASI. A 5 STEM WAS OPENED, BUT IT FELL BELOW THE CORTICAL RIM NOT PROVIDING ENOUGH NECK LENGTH FOR THE PATIENT. SINCE IT DID NOT PROVIDE THE SURGEON WITH THE DESIRED RESULT, ANOTHER 5.5 ACCOLADE PLUS WAS OPENED AND IT SEATED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE 5.5 PLUS IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 16788501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other