BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3781258 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01640
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN INSERT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 5565-S-016, TRI PRESS-FIT STEM 16MM X 100MM, LOT CODE: MBA50; CAT # 5521-B-500, TRI TS BASEPLATE SIZE 5, LOT CODE: HZWI. 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. DOCTOR WOULD NOT RELEASE PRODUCT.

    Description of Event or Problem · 1

    TOTAL IMPLANT EXTRACTION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258833 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 Required Intervention