BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM

    MDR report key: 18573977 · Received January 24, 2024

    Report

    Report Number
    1038671-2024-00126
    Event Type
    Injury
    Date Received
    January 24, 2024
    Date of Event
    January 4, 2024
    Report Date
    February 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 3564809-02-010-03-0240 - LOGIC CR FEMORAL CEM, LEFT, SZ 4 3883850 - 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T 3952000 - 02-012-49-4011 - LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM 3928517 - 200-02-35 - THREE PEG PATELLA 35MM. 3564809 - 02-010-03-0240 - LOGIC CR FEMORAL CEM, LEFT, SZ 4 3883850 - 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T 3928517 - 200-02-35 - THREE PEG PATELLA 35MM. H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION: PLEASE DISREGARD THIS REPORT AS IT WAS SUBMITTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT # 1038671-2024-00152.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2014. THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS. A FULL REVISION. THE PATIENT WAS REVISED ON (B)(6) 2024. THE POLY AND PATELLA IMPLANT WERE SWAPPED. 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
    1140651 LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention SEE H10.