BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM

    MDR report key: 18280074 · Received December 6, 2023

    Report

    Report Number
    1038671-2023-02925
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    November 16, 2023
    Report Date
    March 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001764
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 4913538 - 02-010-01-0325 - LGC FEMORAL PS CEM RIGHT SZ 2.5; 4022746 - 02-012-35-2009 - LGC TIBIA PS MOD INSRT SZ 2 9MM; 5268473 - 02-012-45-2515 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T; 5626308 - 200-02-35 - THREE PEG PATELLA 35MM; 8001018128 - A10012 - GPS IMPLANT KIT V2. H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED 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

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR AND THE LINER WAS EXCHANGED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222069 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| R