BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM

    MDR report key: 23235707 · Received October 7, 2025

    Report

    Report Number
    1038671-2025-03056
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K160484
    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

    CONCOMITANTS: 02-010-01-0225 - LOGIC FEMORAL PS CEM LEFT SZ 2.5: (B)(6). 02-012-35-2509 - LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM: (B)(6). 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T: (B)(6). 200-02-32 - THREE PEG PATELLA 32MM: (B)(6). RECALL NUMBER: Z-0021-2022. THE REVISION WAS LIKELY THE RESULT OF PROSTHESIS WEAR OVER THE COURSE OF OVER 12 YEARS OF IMPLANTATION. POSSIBLE CAUSES FOR POLYETHYLENE DAMAGE INCLUDE HIGH CONTACT STRESSES DURING KNEE FLEXION, UNEQUAL JOINT FORCE DISTRIBUTION BETWEEN THE MEDIAL AND LATERAL SIDES, AND INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, OR ANY COMBINATION OF THESE POSSIBILITIES. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RELEVANT CLINICAL NOTES 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 THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT COMPLAINED OF PAIN, STIFFNESS AND DISSATISFACTION WITH THEIR KNEE REPLACEMENT. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 12 YEARS AND 6 MONTHS AFTER INITIAL IMPLANTATION. PROVIDED IMAGES OF THE TIBIAL INSERT SHOW SIGNS OF PROSTHESIS WEAR. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869276 LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention| H SEE H11