BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE

    MDR report key: 2851092 · Received November 19, 2012

    Report

    Report Number
    1644408-2012-00629
    Event Type
    Other
    Date Received
    November 19, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    OIY
    PMA / PMN Number
    K091956
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY IMPINGEMENT OBSERVED DURING SURGERY. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. THERE WAS A FIVE MINUTE 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 THE PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE SECOND COMPLAINT FOR THIS PART NUMBER, ONE OTHER DUE TO STABILITY/POOR JOINT ISSUES. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE IMPINGEMENT WAS MOST LIKELY DUE TO AN OSTEOPHYTE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - UNSEEN OSTEOPHYTE CAUSED IMPINGEMENT ON THE TIBIAL LINER. THE LINER HAD TO BE REMOVED IN ORDER TO REMOVE OSTEOPHYTE. REPLACED WITH NEW LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D KNEE E-PLUS INSERT, 9MM OIY ENCORE MEDICAL, L.P. 59602699

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention