BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

    MDR report key: 17306059 · Received July 12, 2023

    Report

    Report Number
    1038671-2023-01621
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    July 28, 2022
    Report Date
    April 30, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173638
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 3816353, 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4. 3642670, 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. 3832567, 200-02-32 - THREE PEG PATELLA 32MM.

    Additional Manufacturer Narrative · 0

    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. 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 VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2015. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 7 YEARS 6 MONTHS AFTER THEIR PRIMARY PROCEDURE. ON (B)(6) 2022 OP REPORT INTRAOPERATIVE FINDINGS: VERY DIFFICULT EXPOSURE DUE TO EXTENSIVE SCAR TISSUE LATERAL GUTTER. SURGEON HAD TO CUT AND REMOVE PART OF THE PATELLAR BUTTON TO GAIN ACCESS TO THE LATERAL GUTTER TO RESECT SCAR TISSUE. FEMORAL IMPLANT AND TIBIAL IMPLANT WERE GROSSLY LOOSE WITH SEVERE BONE LOSS FROM OSTEOLYSIS. THERE WAS EXTENSIVE OSTEOLYSIS. SEVERE BONE LOSS IN THE MEDIAL PROXIMAL TIBIA. THE LATERAL FEMORAL CONDYLE HAD SEVERE BONE LOSS WITH THE ENTIRE CONDYLE BONE DAMAGED. THERE WAS A THIN SHELL OF BONE LATERAL. POLYETHYLENE HAD SEVERE AMOUNT OF POLY WEAR PRESENT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190436 LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-012-44-4009 UNK 10885862173638

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention