BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE 132 SIZE 3.5

    MDR report key: 3961752 · Received July 28, 2014

    Report

    Report Number
    0002249697-2014-02877
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 7, 2014
    Report Date
    January 4, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN ACCOLADE STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT COMPLAINT ABOUT ELEVATED COBALT/CHROMIUM LEVELS IN A BLOOD TEST. PATIENT ALSO COMPLAINT ABOUT PAIN IN RIGHT ACCOLADE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439293 ACCOLADE 132 SIZE 3.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 23167201

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other