BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 8994848 · Received September 11, 2019

    Report

    Report Number
    1038671-2019-00448
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    August 12, 2019
    Report Date
    April 23, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) THE EVALUATION NOTED THAT THE REASON FOR THE REVISION REPORTED WAS LIKELY THE RESULT OF BOTH PROSTHESIS WEAR DUE TO THIRD BODY WEAR AND POSSIBLY RELATED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. (D11) CONCOMITANT DEVICE(S): (CN: 02-010-01-0320, SN: (B)(6), LOGIC CC FEMORAL COMPONENT. THE FOLLOWING SECTION(S) HAVE ADDITIONAL INFO; D4 (CATALOG NUMBER, SERIAL NUMBER, UDI NUMBER, ESP DATE). SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (D1) BRAND NAME. (D2) COMMON DEVICE NAME.

    Additional Manufacturer Narrative · 1

    THE ENGINEERING EVALUATION. CONCOMITANT DEVICE(S): (CN: NOT REPORTED, SN: NOT REPORTED) LOGIC CC FEMORAL COMPONENT.

    Description of Event or Problem · 1

    ON (B)(6) THE SURGEON REVISED A LOGIC PS CEMENTED KNEE IMPLANTED IN 2009. THE SURGEON DID A PARTIAL REVISION OF THE FEMUR AND POLY ONLY. THE SURGEON REVISED IT TO A LOGIC CC FEMUR WITH A FEMORAL CONE AND A PS POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790701 OPTETRAK LOGIC LOGIC TIBIA PS MOD INSRT SZ 2 9MM JWH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention