BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3830837 · Received May 23, 2014

    Report

    Report Number
    0002249697-2014-01939
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 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

    THIS MEDWATCH IS A DUPLICATE OF 0002249697-2013-02197. PLEASE DISREGARD.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER AND PRODUCT DESCRIPTION IS UNKNOWN AT THIS TIME. DEVICE REPORTED AS UNKNOWN KNEE COMPONENT. ADDITIONALLY, TWO OTHER DEVICES WERE LISTED IN THIS REPORT AS UNKNOWN KNEE COMPONENTS. BASED ON THE MINIMAL INFORMATION RECEIVED, IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF THE PATIENT'S KNEE FOR AN UNKNOWN REASON IN (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF THE PATIENT'S KNEE FOR AN UNKNOWN REASON IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307911 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention