BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 9848923 · Received March 18, 2020

    Report

    Report Number
    1038671-2020-00248
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    February 27, 2020
    Report Date
    September 24, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054111
    PMA / PMN Number
    K954208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE EVALUATION NOTED THAT BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION OR IS NOSOCOMIAL IN NATURE. SECTION(S): NO INFORMATION HAS BEEN PROVIDED: A2, A4, A5, B6, B7, AND D6.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    APPROXIMATELY 2 WEEKS AFTER A PREVIOUS RIGHT KNEE WASH-OUT AND THE CCK INSERT REPLACEMENT, THIS FEMALE PATIENT DEVELOPED ANOTHER INFECTION. THE CCK INSERT WAS REMOVED ON (B)(6) 2020. THE PROSTHESIS WAS WELL FIXED AND SHOWED NO DEGREE OF MOVEMENT WAS NOTED BY THE SURGEON DURING THE RETRIEVAL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL NOT RETURN DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314435 OPTETRAK CC TIBIAL INSERT SZ 1, 15MM JWH EXACTECH, INC. 208-21-15 UNK 10885862054111

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention