BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON UNIVERSAL B/P BEADED

    MDR report key: 4090554 · Received September 15, 2014

    Report

    Report Number
    0002249697-2014-03482
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K032163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL 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.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    A DURACON TOTAL KNEE WAS REMOVED AND REPLACED WITH A TRIATHLON TS REVISION KNEE, BECAUSE OF LOOSENING. ADDITIONAL INFORMATION RECEIVED FROM SALES REP INDICATED THAT THE TIBIAL BASEPLATE SHOWED SIGNS IF LOOSENING.

    Description of Event or Problem · 1

    A DURACON TOTAL KNEE WAS REMOVED AND REPLACED WITH A TRIATHLON TS REVISION KNEE, BECAUSE OF LOOSENING. ADDITIONAL INFORMATION RECEIVED FROM SALES REP INDICATED THAT THE TIBIAL BASEPLATE SHOWED SIGNS IF LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569644 DURACON UNIVERSAL B/P BEADED IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH CTDVCR

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention