BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 2, 13MM

    MDR report key: 17555392 · Received August 16, 2023

    Report

    Report Number
    1038671-2023-01959
    Event Type
    Injury
    Date Received
    August 16, 2023
    Date of Event
    January 21, 2019
    Report Date
    February 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174338
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND OSTEOLYSIS. 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 AND OSTEOLYSIS COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 2319334 02-012-42-2008 - LOGIC PTS, SIZE 2, 8MM 3718740 204-36-08 - STEM EXTENSION 80L X16 MM 3795675 204-70-00 - TIBIAL STEM EXT. SCREW 3861530 02-012-45-2030 - LGC TIBIAL FIT TRAY CEM SZ PENDING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2015. APPROXIMATELY 3 YEARS AND 6 MONTHS AFTER THE FIRST RIGHT KNEE REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6) 2019. DURING THE (B)(6) 2019, REVISION SURGERY, THE SURGEON FOUND THAT THE POLYETHYLENE FAILED, HAD AN EXCESSIVE AMOUNT OF WEAR, AND WAS DEGRADING/SHEDDING POLYETHYLENE DEBRIS THAT CAUSED METALLOSIS, PAIN, SWELLING, OSTEOLYSIS, SYNOVITIS, BONE LOSS, AND TISSUE DAMAGE. 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
    482991 LOGIC CR TIB INSERT SLOPE++, SZ 2, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 2, 13MM UNK 10885862174338

    Patients

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