BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 2

    MDR report key: 16686885 · Received April 5, 2023

    Report

    Report Number
    1038671-2023-00589
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    March 9, 2023
    Report Date
    June 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001122
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 2554929, 02-012-35-2009 - LOGIC TIBIA PS MOD INSRT SZ 2 9MM. 3677503, 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T. 3832435, 200-02-32 - THREE PEG PATELLA 32MM. H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    AS A RESULT OF ADDITIONAL INFORMATION RECEIVED, SECTION B5 HAS BEEN UPDATED. FURTHER INFORMATION AND/OR RE-OPENED INVESTIGATION RESULTS SHALL BE PROVIDED WITHIN 30 DAYS OF RECEIPT. INITIAL SUBMISSION: ALL FIELDS IN SECTION F SHOULD BE BLANK, THIS IS A MANUFACTURER'S REPORT.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. THE OBSERVED TIBIAL INSERT WEAR MAY HAVE BEEN DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION/EXTENSION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, THIS FEMALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6)2015. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED ON (B)(6)2023 DUE TO A LOOSE FEMUR AND RECALLED POLY. THERE IS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Description of Event or Problem · 0

    AS REPORTED, THIS FEMALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2015 DUE TO OSTEOARTHRITIS. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED ON (B)(6) 2023, APPROXIMATELY 7 YEARS 11 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT POSTOPERATIVE DIAGNOSES: FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR, FEMORAL OSTEOLYSIS, AND LOOSE FEMORAL COMPONENT. SURGEON NOTED SIGNIFICANT OSTEOLYTIC DEBRIS IN THE SYNOVIUM. THE PATELLA WAS FOUND TO BE WELL FIXED WITH NO WEAR. THE INSERT WAS REMOVED AND FOUND TO HAVE OXIDATION AND DELAMINATION. THE TIBIA WAS SOLID BUT THE FEMORAL COMPONENT EASILY DISIMPACTED FROM THE CEMENT MANTLE. WHEN RESECTING THE LATERAL SIDE BENEATH THE CEMENT, THERE WAS A LARGE UNCONTAINED POSTEROLATERAL OSTEOLYTIC CYST. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869207 LOGIC FEMORAL PS CEM LEFT SZ 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-010-01-0220 10885862001122

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention