BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18418801 · Received December 29, 2023

    Report

    Report Number
    1038671-2023-03073
    Event Type
    Injury
    Date Received
    December 29, 2023
    Date of Event
    December 7, 2023
    Report Date
    January 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174529
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 3984396 - 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4. 4133915 - 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T. 3856153 - 02-012-49-4011 - LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM. 4154482 - 200-02-35 - THREE PEG PATELLA 35MM.

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON INVESTIGATION THIS HAS BEEN DISCOVERED TO BE A DUPLICATE CASE, ALL NEW/ADDITIONAL INFORMATION WILL BE APPROPRIATELY PROCESSED AND REPORTED UNDER MFR# 1038671-2023-02354.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 76 Y/O MALE PATIENT'S RIGHT KNEE WAS REVISED. THE PATIENT RETURNED TO THE SURGEONS 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 FULL REVISION. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2023. THE PATIENT UNDERWENT A POLY INSERT SWAP AND PATELLA IMPLANT SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - IMPLANTS WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. UNABLE TO OBTAIN X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841795 LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862174529

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male