BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 15710308 · Received November 1, 2022

    Report

    Report Number
    1038671-2022-01387
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    June 6, 2022
    Report Date
    January 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001849
    PMA / PMN Number
    K093360
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. CONCOMITANTS: 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5, 2843046; 02-010-01-0335 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5, 2945721; 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T, 2579797, 2842184; 1500-S - CEMEX SYSTEM 80G, AA7196; 200-02-32 - THREE PEG PATELLA 32MM, 2993769, 3609655; 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK, 3612440. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    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 AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, INITIAL BILATERAL KNEE IMPLANTED ON (B)(6) 2014, WHO WAS IMPLANTED WITH OPTETRAK DEVICES, INCLUDING OPTETRAK LOGIC TIBIAL INSERTS, SIZE 3.5, 9 MM MADE OF POLYETHYLENE, UNDERWENT A LEFT KNEE REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 7 YEARS 11 MONTHS POST THE INITIAL IMPLANT PROCEDURE UPON INFORMATION AND BELIEF, THE LOOSE COMPONENTS AND OSTEOLYSIS IN PLAINTIFF¿S LEFT KNEE WAS DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. DESPITE UNDERGOING REVISION SURGERY, PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS LEFT KNEE WHICH LIMITS HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459062 LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM UNK 10885862001849

    Patients

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