BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4243399 · Received November 11, 2014

    Report

    Report Number
    0002249697-2014-04234
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS A 81-6403L/R TO 81-6413L/R SCORPIO NRG PS CEMENTLESS FEMORAL COMPONENT. THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    (B)(4) SUPPLEMENTARY REPORT IDENTIFIED THE SCORPIO NRG CEMENTLESS/ SERIES 7000 CEMENTLESS TOTAL KNEE REPLACEMENT COMBINATION AS HAVING A HIGHER THAN ANTICIPATED REVISION RATE COMPARED WITH ALL OTHER TOTAL KNEE PROSTHESES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725219 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention