BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T

    MDR report key: 20762344 · Received November 22, 2024

    Report

    Report Number
    1038671-2024-04480
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    November 2, 2022
    Report Date
    November 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862003997
    PMA / PMN Number
    K101981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    1038671-2024-04479, 1038671-2023-00499, D10: CONCOMITANTS: 4012129 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5, 4060101 200-02-35 - THREE PEG PATELLA 35MM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-04479, 1038671-2023-00499. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, TIBIAL LOOSENING A FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE FEMORAL BONE, WHICH LED TO LOOSENING AT THE CEMENT-IMPLANT INTERFACE AND THE REPORTED PAIN, AND/OR, DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 87 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, AMBULATION OR POSTURAL DIFFICULTIES, AND FAILURE OF IMPLANT. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799082 LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 4049380 10885862003997

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention| H