BEUDAMED
    FDA Adverse Event Other Summary report: N

    3DKNEE

    MDR report key: 3180036 · Received June 13, 2013

    Report

    Report Number
    1644408-2013-00331
    Event Type
    Other
    Date Received
    June 13, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    OIY
    PMA / PMN Number
    K091956
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013 AN AGENT INFORMED DJO SURGICAL OF A REVISION SURGERY INVOLVING THE REPLACEMENT OF A 3D KNEE INSERT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. THE DEVICE HISTORY RECORDS FOR THE 3D KNEE INSERT WERE EXAMINED. THE PRODUCT USED IN THE ORIGINAL SURGERY WAS STERILIZED THROUGH AN ACCEPTABLE HYDROGEN PEROXIDE GAS PLASMA PROCESS AND WAS WITHIN ITS EXPIRATION DATE AT THE TIME OF IMPLANTATION. A REVIEW OF THE IMPLANT DEVICE HISTORY RECORD, PRODUCT COMPLAINT REPORT DATABASE, AND STERILIZATION RECORDS SHOW THAT THIS DEVICE MET STERILIZATION, DESIGN, AND MANUFACTURING REQUIREMENTS. DUE TO THE SHORT TIME BETWEEN THE ORIGINAL SURGERY AND THE REVISION SURGERY IT IS POSSIBLE THAT THE INFECTION WAS ACQUIRED AT THE HOSPITAL (NOSOCOMIAL). IT IS ALSO POSSIBLE THAT THE PATIENT WAS NOT COMPLIANT WITH POST-SURGICAL INSTRUCTIONS. NO INFORMATION WAS SUBMITTED WITH REGARD TO THE SEVERITY OF THE INFECTION. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THE DATA REVIEWED IN THIS REPORT SUPPORTS THAT THIS INCIDENT WAS NOT THE RESULT OF A PRODUCT OR MANUFACTURING PROCESS DEFECT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO POST-OP INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268328 3DKNEE E-PLUS INSERT, 9MM OIY ENCORE MEDICAL, L.P. 59602785

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention