BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE

    MDR report key: 1053356 · Received May 28, 2008

    Report

    Report Number
    9616680-2008-00129
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ASEPTIC LOOSENING AND DR SAID IT WAS PROBABLY AN UNDERSIZED PROSTHESIS." IT HAS NOT BEEN DETERMINED WHETHER THIS IS A RESULT OF THE DEVICE DIMENSIONS OR INCORRECT SELECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 5749401

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention