BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 9MM

    MDR report key: 19239351 · Received May 3, 2024

    Report

    Report Number
    1038671-2024-01043
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 3, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001924
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: SERIAL NUMBER, ITEM NUMBER, AND FULL DESCRIPTION: (B)(6), 203-96-03 - (11-2216) SAW BLADE NEW STRYKER (.050); (B)(6), 02-012-41-5040 - LOGIC TIBIA TRAPTRAY CEM SZ 5F/4T; (B)(6), 200-02-32 - THREE PEG PATELLA 32MM; (B)(6), 02-010-01-0350 - LOGIC FEMORAL PS CEM RIGHT SZ 5; (B)(6), 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050); (B)(6), 203-96-02 - (11-2324) SAW BLADE NEW STRYK (.035). THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 132 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE FUTURE REVISION SURGERY FOR POLYETHYLENE WEAR. THE PATIENT HAS REPORTED PAIN, SWELLING, WEAKNESS, LIMITED RANGE OF MOTION, AND LOSS OF MOBILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306084 LOGIC TIBIA PS MOD INSRT SZ 5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10