BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 8256528 · Received January 17, 2019

    Report

    Report Number
    1038671-2019-01030
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    December 18, 2018
    Report Date
    February 20, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE EVALUATION NOTED THE REVISION REPORTED IN THE EXPERIENCE WAS LIKELY THE RESULT OF A COMBINATION OF FEMORAL SUBSIDENCE, TOO MUCH FLEXION OF THE FEMORAL COMPONENT, AND/OR EXCESSIVE POSTERIOR SLOPE WHICH LED TO WEAR OF THE TIBIAL INSERT. (D11) CONCOMITANT DEVICES: (CN: 170-32-00, SN: 2071873) - BIOLOX DELTA FEMORAL HEAD 32MM OD, +0MM. SECTION(S): NO INFORMATION HAS BEEN PROVIDED: A4, A5, B6, B7, D7. THE FOLLOWING SECTION(S) HAVE ADDITIONAL INFO: D4 (UDI NUMBER) G4, G5, G7, H1, H2, H3, H6, AND H7. SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): SECTION F - F6 AND F8 WERE ENTERED IN ERROR. PLEASE DISREGARD. (G1) UPDATED WITH NEW POST MARKET MANAGER INFORMATION.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    INDEX SURGERY: (B)(6) 2010. REVISION OF LEFT KNEE INSERT DUE TO POLY WEAR LEADING TO OSTEOLYSIS AND SIGNIFICANT BONE LOSS. THE PATIENT WAS STABLE AS THEY LEFT THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49455 OPTETRAK LOGIC TIBIA PS MOD INSRT SZ 4 9MM JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention