BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T

    MDR report key: 20902659 · Received December 11, 2024

    Report

    Report Number
    1038671-2024-04755
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    August 19, 2024
    Report Date
    May 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862003980
    PMA / PMN Number
    K101981
    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

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, PATELLAR LOOSENING, FRACTURE, FEMORAL LOOSENING, AND TIBIAL LOOSENING, OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: (B)(6) 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5. (B)(6) 02-012-45-3525 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T. (B)(6) 200-02-26 - THREE PEG PATELLA 26MM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: XXX, YYYY. 1038671-2024-04692, 1038671-2024-04695, 1038671-2024-04696. IF NO DEVICE RETURN, BUT IMAGES, RADIOGRAPHS, AND/OR OP NOTES RECEIVED FOR INVESTIGATION: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 148 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PROGRESSIVE AND DEBILITATING KNEE PAIN SECONDARY TO ASEPTIC LOOSENING, POLYETHYLENE WAR AND OSTEOLYSIS. REVISION OPERATIVE REPORTS WERE PROVIDED. INTRAOPERATIVELY THE SURGEON OBSERVED ASEPTIC LOOSENING OF THE FEMUR AND TIBIAL TRAY, POLYETHYLENE WEAR OF THE INSERT, SIGNIFICANT SURFACE DAMAGE, DELAMINATION AND PITTING ON THE PATELLA, WHICH WAS FRACTURED AND LOOSE. IT WAS NOTED THE SURGICAL PROCEDURE WAS SIGNIFICANTLY DIFFICULT DUE TO PATIENT'S HEIGHT AND WEIGHT WHICH REQUIRED ADDITIONAL SURGICAL DISSECTION. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. IMPACTOR AND THE TIBIAL COMPONENT CAREFULLY REMOVED, WHICH WAS ALSO 02-012-35-3511 - LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM. SERIAL: (B)(6). 510K: K093360 UDI: (B)(4). PRODUCT CODE: JWH. X-RAY: NO. OPERATIVE NOTES: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2403564 LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862003980

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| H SEE H11