BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T

    MDR report key: 21079664 · Received January 6, 2025

    Report

    Report Number
    1038671-2025-00079
    Event Type
    Injury
    Date Received
    January 6, 2025
    Date of Event
    July 12, 2022
    Report Date
    August 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862003997
    PMA / PMN Number
    K101981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: (B)(4) 02-010-01-0335 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5 (B)(4) 1510-S - CEMEX SYSTEM FAST 70 GM (B)(4) 200-02-35 -THREE PEG PATELLA 35MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOWING FIELD THAT WAS ENTERED ERRONEOUSLY IN THE INITIAL REPORT: G3: 24-FEB-2023. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, E, G. THE REASON FOR THE REPORTED EVENT WAS LIKELY DUE TO A PERIPROSTHETIC BONE FRACTURE. THE CAUSE OF THE BONE FRACTURE CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO A PATIENT CONDITION, A TRAUMATIC EVENT, AND/OR SURGICAL TECHNIQUES. HOWEVER, THIS CANNOT 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

    LEGAL CASE-USA. PATIENT ID: (B)(6) + RIGHT KNEE. IT WAS REPORTED THAT DURING THE PATIENT'S RIGHT KNEE REVISION SURGERY AND WHILE REMOVING THE TIBIAL COMPONENT, AN INTRAOPERATIVE SURGICAL INTERVENTION WAS PERFORMED DUE TO A LARGE SECTION OF POSTERIOR PROXIMAL TIBIA BONE THAT WAS ADHERENT TO THE POSTERIOR ASPECT OF THE KEEL CREATING A FRACTURE DEFECT TO THE POSTERIOR PROXIMAL TIBIA UPON REMOVAL. IT WAS NOTED THAT THE LARGE BONE FRAGMENT CONTAINED POSTERIOR CAPSULAR SOFT TISSUE AND BLOOD SUPPLY AND WAS FREED FROM THE TIBIAL COMPONENT AND REAPPROXIMATED IN THE ANATOMIC POSITION. IT WAS NOTED THAT 70% OF THE PROXIMAL TIBIA REMAINED INTACT WITHOUT COMPROMISE AND NO DIAPHYSEAL EXTENSION. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL NO. (B)(6); 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T UDI NUMBER: (B)(4). 510(K) NUMBER: K101981 PRODUCT CODE: JWH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136771 LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862003997

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other SEE H11.