BEUDAMED
    FDA Adverse Event Summary report: N

    3DKNEE

    MDR report key: 3000273 · Received March 12, 2013

    Report

    Report Number
    1644408-2013-00140
    Date Received
    March 12, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS INSTABILITY AFTER 4.75 YEARS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 15TH COMPLAINT FOR THIS PART NUMBER: (B)(4). THE ROOT CAUSE FOR THE INSTABILITY WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. SEVERAL FACTORS NOT RELATED TO THE IMPLANT CAN PLAY A ROLE IN INSTABILITY SUCH AS; LOOSE JOINT FROM INADEQUATE SOFT TISSUE, IMPLANT SELECTION, OR PATIENT ACTIVITY.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT'S RIGHT KNEE IS UNSTABLE, THE SURGEON REVISED HIM FROM A SIZE 6, 9MM TO A SIZE 6, 15MM TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103781 3DKNEE DCM INSERT, 9MM JWH ENCORE MEDICAL, L.P. 53910017

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention