BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 15581378 · Received October 11, 2022

    Report

    Report Number
    1038671-2022-01288
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    September 21, 2020
    Report Date
    November 10, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174444
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. CONCOMITANTS: 2034742 200-03-35 - ONE PEG PATELLA 35MM; 2110927 02-010-03-0240 - LOGIC CR FEMORAL CEM, LEFT, SZ 4; 2644652 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T. RECALL: Z-0021-2022. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: 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; HOWEVER, IT MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO PROSTHESIS WEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A MALE PATIENT, INITIALLY IMPLANTED WITH AN OPTETRAK SYSTEM ON HIS LEFT KNEE ON (B)(6) 2013, UNDERWENT REVISION PROCEDURE ON (B)(6) 2020, APPROXIMATELY 7 YEARS 2 MONTHS POST THE INITIAL PROCEDURE, FOR REASONS UNKNOWN. THE SURGEON FOUND THAT THE OPTETRAK POLYETHYLENE HAD SEVERELY WORN AND CAUSED OSTEOLYSIS OF THE TIBIAL AND FEMORAL BONE, AS WELL AS LOOSENING OF THE REMAINDER OF THE DEVICE. THE SURGEON REMOVED THE FAILED LEFT SIDE OPTETRAK IMPLANT AND REPLACED IT WITH ANOTHER IMPLANT. NO FURTHER INFORMATION KNOWN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305926 LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 4, 9MM UNK 10885862174444

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10