BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 13423046 · Received February 2, 2022

    Report

    Report Number
    1038671-2022-00131
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    December 28, 2020
    Report Date
    July 1, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001818
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND PRE-REVISION X-RAYS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 10.76 YEARS SINCE INITIAL IMPLANT, THIS MALE PATIENT WITH BMI 26.4 UNDERWENT A LEFT SIDE TKA AND WAS IMPLANTED WITH AN EXACTECH UHMWPE INSERT, SERIAL #:(B)(4). ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. 510K: K033883.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85843 OPTETRAK LOGIC TIBIA PS MOD INSRT SZ 3 11MM JWH EXACTECH, INC. 02-012-35-3011 UNK 10885862001818

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H