BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18196988 · Received November 22, 2023

    Report

    Report Number
    1038671-2023-02844
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    January 1, 2023
    Report Date
    June 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 CLINICAL CODE AND COMPONENT CODE. ADDITIONAL INFORMATION: H6 PROBLEM CODE.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    H3: THE MOST LIKELY CAUSE FOR THE REVISION IS PROSTHESIS WEAR AS REPORTED. A CONTRIBUTING FACTOR TO THE EXTENT OF WEAR ON THE DEVICE MAY BE THE RESULT OF BEING PACKAGED IN A NON-CONFORMING BAG FOR MORE THAN 5 YEARS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6 PROBLEM CODE AND INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 4571317 02-010-03-0310 - LOGIC CR,1 4744858 02-012-45-1010 - LOGIC FIT.1F/1T 862336 TN190-119-05 - M-CLASS 19X1.19X105 862363 TN193-119-90 - M-CLASS 19/13X 1.19X90MM.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT PRESENTED COMPLAINING OF KNEE SWELLING AND PAIN, AND THE SURGEON DIAGNOSED WEAR OF THE TIBIAL INSERT. THE PATIENT WAS REVISED ON AN UNKNOWN DATE. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. NO METALLOSIS WAS FOUND. THERE WAS NO PROBLEM WITH THE LOCKING MECHANISM OF THE TIBIAL TRAY. ALL PROLIFERATIVE TISSUES WERE REMOVED AND ONLY THE INSERT WAS REPLACED. THERE WAS NO REPORTED 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
    2041254 LOGIC CR TIB INSERT SLOPE++, SZ 1, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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