BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM

    MDR report key: 23622342 · Received November 21, 2025

    Report

    Report Number
    1038671-2025-03408
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    July 3, 2024
    Report Date
    November 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001764
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-010-01-0225 - LOGIC FEMORAL PS CEM LEFT SZ 2.5: SN# (B)(6), 02-012-41-2515 - LOGIC TIBIA TRAPTRAY CEM SZ 2.5F/1.5T: SN# (B)(6). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS 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 TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED FEMORAL KNEE DEBONDING/LOOSENING AND BROKEN POLYETHYLENE LINER. AS A RESULT, APPROXIMATELY 10 YEARS AND 7 MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 FOR THIS EVENT/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076654 LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001764

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization SEE H11