BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM

    MDR report key: 17145533 · Received June 16, 2023

    Report

    Report Number
    1038671-2023-01383
    Event Type
    Injury
    Date Received
    June 16, 2023
    Date of Event
    June 13, 2022
    Report Date
    October 9, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001863
    PMA / PMN Number
    K093360
    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

    PENDING INVESTIGATION. D10. CONCOMITANTS: 3933725 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T. 3950274 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5. 4123089 200-02-35 - THREE PEG PATELLA 35MM.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONSMANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2016. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 6 YEARS 4 MONTHS AFTER THEIR INITIAL IMPLANTATION. PATIENT CLAIMS TO HAVE SUFFERED FROM PAIN, SWELLING, LOSS OF MOTION, WEAKNESS, AND GIVING WAY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014606 LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-012-35-3513 UNK 10885862001863

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention