BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 1, 9MM

    MDR report key: 15708061 · Received November 1, 2022

    Report

    Report Number
    1038671-2022-01380
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    September 27, 2022
    Report Date
    March 25, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174208
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 2160093, 02-010-03-0210 - LOGIC CR CEMENT FEMORAL LEFT, 1; 4828295, 02-012-45-1010 - LOGIC FIT CEMENT TIVIAL TRAY 1F/1T; 4000019040, A10012 - GPS DISPOSABLE KIT; 993320, TN190-119-05 - OSCILLATING BLADE M-CLASS 19X1.19X105; 1017596, TN193-119-90 - OSCILLATOR BLADE M-CLASS 19/13X 1.19X90MM; UNASSIGNED, Z99007 - LOGIC TKA SET; UNASSIGNED, ZINFO-01 - INFORMATION PROVISION FEE; UNASSIGNED, ZOSCL-01 - OSCILLATOR; UNASSIGNED, ZREAM-01 - REAMER.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF WEAR OF THE TIBIAL INSERT, WHICH LED TO THE PATIENT¿S PAIN. A CONTRIBUTING FACTOR TO THE SEVERITY OF THE WEAR AND DELAMINATION MAY HAVE BEEN RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 4316, APPROPRIATE TERM/CODE NOT AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL LEFT TKA, THIS 71 Y/O FEMALE PATIENT WAS REVISED DUE TO WEAR OF THE TIBIAL INSERT. THE PATIENT WAS EXPERIENCING KNEE SWELLING AND PAIN. BREAKAGE AND WEAR WERE OBSERVED ON THE RETRIEVED TIBIAL INSERT. THE SURGEON DECIDED THAT THERE WAS NO PROBLEM FOUND ON THE LOCKING MECHANISM OF THE TIBIAL TRAY, AND AFTER REMOVING ALL PROLIFERATIVE TISSUES, ONLY THE INSERT WAS REPLACED. DEVICE IS NOT RETUNING, DEVICE IS GIVEN TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059379 LOGIC CR TIB INSERT SLOPE++, SZ 1, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-49-1009 UNK 10885862174208

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention