BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 9MM

    MDR report key: 20163422 · Received September 6, 2024

    Report

    Report Number
    1038671-2024-03344
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    September 9, 2024
    Report Date
    July 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001801
    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: ((B)(6)) 02-012-35-3009 - LOGIC TIBIA PS MOD INSRT SZ 3 9MM. ((B)(6)) 02-012-35-3009 - LOGIC TIBIA PS MOD INSRT SZ 3 9MM. ((B)(6)) 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T. ((B)(6)) 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3. ((B)(6)) 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T. ((B)(6)) 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3. ((B)(6)) 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM. ((B)(6)) 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM. ((B)(6)) 200-02-32 - THREE PEG PATELLA 32MM. ((B)(6)) 200-02-32 - THREE PEG PATELLA 32MM. 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

    H6: CORRECTED COMPONENT AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    QIT WAS REPORTED THAT APPROXIMATELY 71 MONTHS AFTER A TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302552 LOGIC TIBIA PS MOD INSRT SZ 3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001801

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown SEE H11