BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T

    MDR report key: 20534300 · Received October 25, 2024

    Report

    Report Number
    1038671-2024-04123
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    April 10, 2018
    Report Date
    November 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862003935
    PMA / PMN Number
    K101981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: (2421001) 02-012-35-2511 - LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM. (2593125) 02-010-01-0325 - LOGIC FEMORAL PS CEM RIGHT SZ 2.5. (2519017) 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.

    Description of Event or Problem · 0

    LEGAL CASE ¿ USA (MDL NO. (B)(4) CASE (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 62 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR INTRAOPERATIVE BONE FRACTURE DURING REMOVAL OF TIBIAL TRAY COMPONENT. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819834 LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862003935

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R SEE H11