BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE

    MDR report key: 1853244 · Received September 30, 2010

    Report

    Report Number
    1644408-2010-00506
    Event Type
    Other
    Date Received
    September 30, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE REVISION SURGERY WAS IDENTIFIED AS INSTABILITY AFTER 4.7 YEARS OF PT USE. THERE IS NO INFO REPORTED ABOUT ANY PT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED ONE NON-CONFORMING MATERIAL REPORT #7794 ASSOCIATED WITH THIS PRODUCT FOR ONE PIECE WITH A SCRATCH ON THE TIBIAL INSERT WHICH WAS DISPOSITIONED AS SCRAP AND NOT USED IN THE LOT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. SEVERAL FACTORS NOT RELATED TO THE IMPLANT CAN PLAY A ROLE IN INSTABILITY; SUCH AS LOOSE JOINT FROM INADEQUATE SOFT TISSUE AND IMPLANT SELECTION. THE 392-11-612 INSERT WAS REPLACED WITH A 360-11-108 PS INSERT, MOST LIKELY FOR STABILITY.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT WAS FEELING PAIN AND SWELLING IN THE KNEE. COMPONENTS WERE TOO LOOSE. EVERYTHING WAS TAKEN OUT EXCEPT THE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D KNEE NON POROUS FEMUR JWH ENCORE MEDICAL, L.P. 447072

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 392-11-612, LOT 458962| 324-01-110, LOT 926901