BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_CORK_PRODUCT

    MDR report key: 3924345 · Received July 9, 2014

    Report

    Report Number
    0002249697-2014-02593
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 12, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF AN UNKNOWN TIBIAL INSERT. IT WAS REPORTED THAT THE REVISION SURGERY TOOK PLACE TODAY (B)(6) 2014. THE SURGEON IMPLANTED: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401455 UNKNOWN_CORK_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R