BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 6, 9MM

    MDR report key: 17641357 · Received August 29, 2023

    Report

    Report Number
    1038671-2023-02073
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    August 3, 2023
    Report Date
    February 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174680
    PMA / PMN Number
    K121307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): FEMORAL COMPONENT CR, CEMENTED SIZE - 02-010-03-0360 - 3460195. FIT TIBIAL TRAY CEMENTED SIZE 6F/5T - 02-012-45-6050 - 3680758. THREE PEG PATELLA, 38MM - 200-02-38 - 3840256.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT AND/OR PATELLA POSSIBLY DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION/EXTENSION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE CAUSE AND EXTENT OF THE PROSTHESIS WEAR CANNOT BE DETERMINED BECAUSE MINIMAL INFORMATION WAS PROVIDED, THE REVISED COMPONENTS WERE NOT RETURNED FOR EVALUATION, AND NO RADIOGRAPHS OR IMAGES WERE PROVIDED. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 734, BEARINGS.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT AND/OR PATELLA POSSIBLY DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION/EXTENSION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE CAUSE AND EXTENT OF THE PROSTHESIS WEAR CANNOT BE DETERMINED BECAUSE MINIMAL INFORMATION WAS PROVIDED, THE REVISED COMPONENTS WERE NOT RETURNED FOR EVALUATION, AND NO RADIOGRAPHS OR IMAGES WERE 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, APPROXIMATELY 8 YEARS POST OP INITIAL RIGHT TKA, THIS 69 Y/O MALE PATIENT WAS REVISED DUE TO POLY WEAR. EVERYTHING WAS REMOVED AND REPLACED BY COMPETITORS DEVICES. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT . NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. UNABLE TO OBTAIN PHOTOS/X-RAYS. PRODUCT NOT RETURNING - DISPOSED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058298 LOGIC CR TIB INSERT SLOPE+, SZ 6, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862174680

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male SEE H10.