BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 1 9MM

    MDR report key: 16461681 · Received March 1, 2023

    Report

    Report Number
    1038671-2023-00310
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    February 2, 2021
    Report Date
    January 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001689
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODE: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANT MEDICAL PRODUCTS: 3569072 02-010-01-0210 - LOGIC FEMORAL PS CEM LEFT SZ 1, 4382600 02-012-45-1010 - LGC TIBIAL FIT TRAY CEM SZ 1F / 1T, 5161787 200-02-35 - THREE PEG PATELLA 35MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION- BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, AND LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL LEFT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2018 AND WAS IMPLANTED WITH AN OPTETRAK DEVICE. IN 2019 AND 2020, PLAINTIFF EXPERIENCED EXTREME PAIN AND DISCOMFORT IN HER LEFT KNEE WHICH LIMITED HER ACTIVITIES OF DAILY LIVING AND HER QUALITY OF LIFE. PLAINTIFF UNDERWENT REVISION SURGERY ON HER LEFT KNEE ON (B)(6) 2021, APPROXIMATELY 2 YEARS 11 MONTHS POST INITIAL PROCEDURE, AND THE POLYETHYLENE LINER AND THE ENTIRE FEMUR AND TIBIAL COMPONENTS WERE REVISED. PATHOLOGY INDICATED, IN PART, ¿FIBROUS TISSUE WITH MARKED FOREIGN-BODY GIANT CELL REACTION". NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844895 LOGIC TIBIA PS MOD INSRT SZ 1 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 1 9MM UNK 10885862001689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention