BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_CORK_PRODUCT

    MDR report key: 4090555 · Received September 15, 2014

    Report

    Report Number
    0002249697-2014-03484
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 SIZE 2 ACCOLADE TMZF 127. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD LEFT HIP REVISED DUE TO ELEVATED COBALT AND CHROMIUM LEVELS (METALLOSIS). SURGEON CONVERTED TO A CONSTRAINED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570256 UNKNOWN_CORK_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R