BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2 9MM

    MDR report key: 20233221 · Received September 16, 2024

    Report

    Report Number
    1038671-2024-03545
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    August 28, 2024
    Report Date
    June 26, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001726
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 02-012-39-2030 - LOGIC TIBIA FIN TRAY CEM SZ 2F/3T 1834573.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING AND PAIN OVER 13 YEARS OF IMPLANTATION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND PRE-REVISION X-RAYS WERE INCONCLUSIVE. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. THE RADIOGRAPH SUGGESTS THAT THE MEDIAL ASPECT OF THE KNEE WAS UNDER HIGHER IN-VIVO LOADING THAT MAY CORRESPOND TO MEDIAL WEAR OR INSTABILITY OF THE KNEE. HOWEVER, PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLA COULD NOT BE CONFIRMED DUE TO INSUFFICIENT VIEWS OF THE POLYETHYLENE IN THE PROVIDED IMAGE AND THE DEVICES WERE NOT RETURNED FOR EVALUATION. 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

    IT WAS REPORTED THAT THIS FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 13 YEARS 4 MONTHS POST OP. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR, RECALLED POLY AND PATELLA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: CHAIN OF COMMAND DUE TO RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509584 LOGIC TIBIA PS MOD INSRT SZ 2 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention