BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 9MM

    MDR report key: 16461498 · Received March 1, 2023

    Report

    Report Number
    1038671-2023-00305
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    August 27, 2021
    Report Date
    October 20, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001801
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: PENDING EVALUATION. CONCOMITANT MEDICAL DEVICE(S): 5062140, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK; 3954900, 201-78-81 - 3" TROCAR, MOD. HEX 2PK; 4503383, 201-78-81 - 3" TROCAR, MOD. HEX 2PK; 4983821, 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3; 5055870, 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T; 4866481, 200-02-32 - THREE PEG PATELLA 32MM.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, OSTEOLYSIS, AND INSUFFICIENT BONDS BETWEEN THE IMPLANTS AND THE BONES WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. IT IS POSSIBLE THAT A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING BAG FOR MORE THAN 5 YEARS BEFORE IT WAS IMPLANTED. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR, OSTEOLYSIS, AND LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL, APPROXIMATELY 3.5 YEARS POST OP THE INITIAL RIGHT TKA, THIS FEMALE PATIENT WAS REVISED DUE TO WORSENING PAIN, INSTABILITY, AND MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PROSTHETIC JOINT. DURING THE SURGERY, SURGEON NOTED ¿MASSIVE¿ FEMORAL OSTEOLYSIS, ¿SEVERE¿ TIBIAL OSTEOLYSIS AS SEVERE, AND A ¿PROXIMAL TIBIA FRACTURE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123759 LOGIC TIBIA PS MOD INSRT SZ 3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862001801

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention