BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 15MM

    MDR report key: 17362695 · Received July 20, 2023

    Report

    Report Number
    1038671-2023-01722
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    October 24, 2022
    Report Date
    December 2, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001955
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6), 02-010-01-0250 - LOGIC FEMORAL PS CEM LEFT SZ 5; (B)(6), 02-010-01-0350 - LOGIC FEMORAL PS CEM RIGHT SZ 5; (B)(6), 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T; (B)(6), 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T; (B)(6), 200-02-41 - THREE PEG PATELLA 41MM; (B)(6), 200-02-41 - THREE PEG PATELLA 41MM; (B)(6), 02-012-35-5013 - LOGIC TIBIA PS MOD INSRT SZ 5 13MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE MALE PATIENT HAD A BILATERAL KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A BILATERAL REVISION ON (B)(6) 2022. 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. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: FAILED BILATERAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC FEMORAL LOOSENING AND POLYETHYLENE WEAR. FEMORAL COMPONENT WAS LOOSE WITH CYST FOUND POSTERIOR LATERAL. PATIENT WAS AWAKENED AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139503 LOGIC TIBIA PS MOD INSRT SZ 5 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 15MM UNK 10885862001955

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention SEE H10.