BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON CS TIBIA INSERT MED 9

    MDR report key: 3910836 · Received July 2, 2014

    Report

    Report Number
    0002249697-2014-02532
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    January 1, 2006
    Report Date
    June 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K032163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN RIGHT STRYKER KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) INCHES IN HEIGHT. AN EVENT REGARDING BASEPLATE LOOSENING INVOLVING A DURACON CS TIBIA INSERT MED 9 WAS REPORTED. IT WAS REPORTED CONSTANT PAIN AND DOCTOR DID AN MRI AND SAID IT SHOWS THE LOWER PLATE IS LOOSE. NO ALLEGATIONS WERE MADE REGARDING THE INSERT. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    PATIENT REPORTS CONSTANT PAIN. SURGEON DID AN MRI AND SAID IT SHOWS THE LOWER PLATE IS LOOSE. PATIENT SAYS EVERY DOCTOR SHE HAS SEEN DOES NOT WANT TO PERFORM A REVISION AND PATIENT DOESN'T KNOW WHAT TO DO NEXT.

    Description of Event or Problem · 1

    PATIENT REPORTS CONSTANT PAIN. SURGEON DID AN MRI AND SAID IT SHOWS THE LOWER PLATE IS LOOSE. PATIENT SAYS EVERY DOCTOR SHE HAS SEEN DOES NOT WANT TO PERFORM A REVISION AND PATIENT DOESN'T KNOW WHAT TO DO NEXT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386947 DURACON CS TIBIA INSERT MED 9 IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH LP646

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other