BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4221726 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04147
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN STRYKER TRIATHLON KNEE SYSTEM. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED: THIS LETTER IS TO INFORM YOU OF THE POSSIBILITY OF EARLY CLINICAL FAILURES IDENTIFIED IN TEN PATIENTS UNDERGOING NON CEMENTED TOTAL KNEE ARTHROPLASTY UTILIZING THE STRYKER TRIATHLON SYSTEM. ALL OF THESE PATIENTS EXHIBITED RADIOGRAPHIC CHANGES SUGGESTING EARLY FAILURE. ONE OF THE PATIENTS REQUIRED A REVISION IMMEDIATELY POSTOPERATIVELY AND ANOTHER PATIENT IS PENDING A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702449 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other