BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM

    MDR report key: 16419980 · Received February 22, 2023

    Report

    Report Number
    1038671-2023-00205
    Event Type
    Injury
    Date Received
    February 22, 2023
    Date of Event
    February 2, 2023
    Report Date
    April 29, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174413
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS MOST LIKELY THE RESULT OF PROSTHESIS WEAR INITIATED BY UNINTENDED CONTACT BETWEEN THE TIBIAL INSERT AND TROCHLEAR RIDGES OF THE FEMORAL COMPONENT. POTENTIAL CONTRIBUTING FACTORS TO THE SEQUENCE OF EVENTS MAY INCLUDE INSTABILITY OF THE KNEE JOINT, COMPONENT ALIGNMENT, AND/OR PATIENT-RELATED CONDITIONS. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: (B)(4), 02-010-03-0330 - LOGIC CR FEMORAL CEM, RIGHT, SZ 3. (B)(4), 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T. (B)(4), 200-02-35 - THREE PEG PATELLA 35MM. RECALL NUMBER: Z-0021-2022.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT WAS REVISED ON (B)(6) 2023 AS THE POLY HAD DELAMINATED. THERE WAS NO REPORTED BREAKAGE OF DEVICES OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134583 LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-49-3009 10885862174413

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention SEE H10.