BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL LOGIC PS CEM SZ 4 RT

    MDR report key: 11697819 · Received April 20, 2021

    Report

    Report Number
    1038671-2021-00182
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 20, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001252
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: INSERT TIBIA LOGIC PS SZ4 9MM. TRAY TIBIA LOGIC CM SZ 4F/3T. PATELLA THREE PEG 32MM. AS REPORTED, APPROXIMATELY 11 YEARS POSTOP THE INITIAL RIGHT TKA,A REVISION KNEE SURGERY ON A (B)(6) Y/O MALE PATIENT WAS SCHEDULED. THE PATIENT RETURNED EXPERIENCING KNEE PAIN. IT WAS NOTED THAT THE PATIENT WAS A PLUMBER AND PROBABLY SPENT A LOT OF TIME ON HIS KNEES. THE PATIENT HAD A SIZE 4 LOGIC FEMUR A SIZE 4F/3T AND A 9MM INSERT. THE FEMUR WAS A GOOD FIT, SO WE REVISED TO A 4 OPTETRAK CCK FEMUR USING 2 10MM POSTERIOR AUGMENTS AND ONE 10MM DISTAL AUGMENT. TIBIA WAS REVISED TO A 4F/3T AND AN 11MM CCK INSERT WAS USED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE HOSPITAL RETAINS ALL RETRIEVALS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN, MANUFACTURING, OR PATIENT RELATED ISSUES. THE CAUSE OF THE PAIN AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY IS RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 11 YEARS POSTOP THE INITIAL RIGHT TKA,A REVISION KNEE SURGERY ON A (B)(6) Y/O MALE PATIENT WAS REVISED. THE PATIENT RETURNED EXPERIENCING KNEE PAIN. IT WAS NOTED THAT THE PATIENT WAS A PLUMBER AND PROBABLY SPENT A LOT OF TIME ON HIS KNEES. THE PATIENT HAD A SIZE 4 LOGIC FEMUR A SIZE 4F/3T AND A 9MM INSERT. THE FEMUR WAS A GOOD FIT, SO WE REVISED TO A 4 OPTETRAK CCK FEMUR USING 2 10MM POSTERIOR AUGMENTS AND ONE 10MM DISTAL AUGMENT. TIBIA WAS REVISED TO A 4F/3T AND AN 11MM CCK INSERT WAS USED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE HOSPITAL RETAINS ALL RETRIEVALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589875 FEMORAL LOGIC PS CEM SZ 4 RT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. FEMORAL LOGIC PS CEM SZ 4 RT UNK 10885862001252

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention| S