BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3781104 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01713
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN INSERT. OTHER DEVICES LISTED IN THIS REPORT: CAT # UNKNOWN, LOT # UNKNOWN, DESCRIPTION: UNKNOWN BUSHINGS; CAT # UNKNOWN, LOT # UNKNOWN, DESCRIPTION: UNKNOWN BUMPER; CAT # UNKNOWN, LOT # UNKNOWN, DESCRIPTION: UNKNOWN AXLE; CAT # UNKNOWN, LOT # UNKNOWN, DESCRIPTION: UNKNOWN SLEEVE; CAT # UNKNOWN, LOT # UNKNOWN, DESCRIPTION: UNKNOWN ROTATING HINGE. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF AN INFECTED KNEE, WASHOUT AND CHANGE OF COMPONENTS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259862 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention