BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4130400 · Received September 30, 2014

    Report

    Report Number
    0002249697-2014-03696
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN STANDARD TRIATHLON BASEPLATE.AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    REVIEW OF THE POST MARKET SURVEILLANCE SURVEY NOTED THAT SURGEON ONLY USES "UNIVERSAL BASEPLATES DUE TO EARLY LOOSENING WITH KEEL AND OCCASIONAL NEED FOR TS." IT WAS CLARIFIED THAT THE SURGEON BELIEVES OTHER BASEPLATES EXPERIENCE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609249 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other