BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 5, 13MM

    MDR report key: 19967490 · Received August 12, 2024

    Report

    Report Number
    1038671-2024-02796
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    December 18, 2023
    Report Date
    March 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230584
    PMA / PMN Number
    K123342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT PRODUCTS: (B)(6) - 02-010-03-0350 - LOGIC CR FEMORAL CEM, RIGHT, SZ 5. (B)(6) - 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. (B)(6) - 200-02-35 - THREE PEG PATELLA 35MM. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION: PLEASE DISREGARD THIS REPORT AS IT WAS SUBMITTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT 1038671-2024-02796.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 73 MONTHS AFTER A TOTAL RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, EFFUSION, OSTEOLYSIS, SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2247649 LOGIC TIB INSERT IMPL CRC, SZ 5, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862230584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11