BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM

    MDR report key: 17361732 · Received July 20, 2023

    Report

    Report Number
    1038671-2023-01718
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    February 27, 2014
    Report Date
    October 14, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001863
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 2516752 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5. 2935884 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T. 2956579 200-02-35 - THREE PEG PATELLA 35MM. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED HEALTH EFFECT CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR, INSTABILITY, AND LOOSENING AND/OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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 THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2014. THIS HAS NOT YET BEEN EXPLANTED. PATIENT BEGAN EXPERIENCING SIGNIFICANT PAIN, SWELLING AND POPPING. ON (B)(6) 2022 THE PATIENT REPORTED SWELLING AFTER DAILY ACTIVITIES. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. 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
    905320 LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM UNK 10885862001863

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNK.