BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 6 11MM

    MDR report key: 17710200 · Received September 8, 2023

    Report

    Report Number
    1038671-2023-02194
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    December 31, 2018
    Report Date
    September 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001979
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: SERIAL NUMBER, (B)(6), ITEM NUMBER, 02-012-45-6050 AND, FULL DESCRIPTION, LGC TIBIAL FIT TRAY CEM SZ 6F / 5T, (B)(6), 02-010-01-0260 - LOGIC FEMORAL PS CEM LEFT SZ 6, (B)(6), 200-02-41 - THREE PEG PATELLA 41MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, F, G. THE REASON FOR THE JOINT EFFUSION REPORTED CANNOT BE CONCLUSIVELY DETERMINED AND THE REPORTED EVENT COULD NOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INFLAMMATION ON (B)(6) 2015. THE PATIENT PRESENTED ON (B)(6) 2018 AND AFTER VERY ACTIVE END OF THE YEAR DEVELOPED LEFT KNEE EFFUSION WITH PAIN. EFFUSION NEVER WENT AWAY SO CAME IN FOR F/U. RADIOGRAPHIC IMAGES SHOWED NO CHANGES BUT NOTED EFFUSION ON LATERAL VIEW. ASPIRATION NEGATIVE FOR INFECTION. WILL CONTINUE TO MONITOR. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE, UNLIKELY RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INFLAMMATION. THE PATIENT PRESENTED SYMPTOMS TO DOCTOR AND AFTER A VERY ACTIVE END OF THE YEAR DEVELOPED LEFT KNEE EFFUSION WITH PAIN. EFFUSION NEVER WENT AWAY SO CAME IN FOR F/U. RADIOGRAPHIC IMAGES SHOWED NO CHANGES BUT NOTED EFFUSION ON LATERAL VIEW. ASPIRATION NEGATIVE FOR INFECTION. WILL CONTINUE TO MONITOR. THE REPORTED EVENT COULD NOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898260 LOGIC TIBIA PS MOD INSRT SZ 6 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 6 11MM 10885862001979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10.