BEUDAMED
    FDA Adverse Event Summary report: N

    3DKNEE

    MDR report key: 3011067 · Received March 19, 2013

    Report

    Report Number
    1644408-2013-00157
    Date Received
    March 19, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 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 ON (B)(6) 2013 WAS IDENTIFIED AS AN INFECTION. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2012. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE DISABILITY OR PERMANENT DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. 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. THE DEVICE HISTORY RECORDS FOR THE REPORTED COMPONENTS INVOLVED WERE EXAMINED. A REVIEW OF THE STERILIZATION RECORDS SHOW THAT THE REPORTED DEVICES HAD ALL RECEIVED AN ADEQUATE 25-40 KGY GAMMA RADIATION STERILIZATION DOSE AND WERE WITHIN THEIR RESPECTIVE EXPIRATION DATES AT THE TIME OF THE ORIGINAL SURGERY. 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. 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. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO INFECTION THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. THE DATA REVIEWED IN THIS REPORT SUPPORTS THAT THIS INCIDENT WAS NOT THE RESULT OF A PRODUCT OR PROCESS DEFECT.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT BECAME INFECTED FOLLOWING A TOTAL KNEE ARTHROPLASTY. THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT ALONG WITH A POLY EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114433 3DKNEE DCM INSERT, 9MM JWH ENCORE MEDICAL, L.P. 59602340

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention