BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 19623726 · Received June 27, 2024

    Report

    Report Number
    1038671-2024-02167
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    June 6, 2024
    Report Date
    March 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001771
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4438813 02-010-01-0325 - LOGIC FEMORAL PS CEM RIGHT SZ 2.5, 4487372 02-012-45-2515 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T, 4653981 200-02-32 - THREE PEG PATELLA 32MM, 4665296 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM, 4666817 204-70-00 - TIBIAL STEM EXT. SCREW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 88 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, A PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS THE "(LYSIS) DUE TO THE SPINE OF THE LINER BEING RUBBED UP AGAINST". PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: UNABLE TO OBTAIN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448758 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001771

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention SEE H11