BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4031195 · Received August 22, 2014

    Report

    Report Number
    0002249697-2014-03234
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN PCA LINER 26MM 10DEG. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A LEFT HIP DUE TO POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509387 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention