BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 9MM

    MDR report key: 17625309 · Received August 25, 2023

    Report

    Report Number
    1038671-2023-02052
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    January 10, 2013
    Report Date
    October 23, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001924
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1038671-2024-04094 H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, IMPACT CODE, PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR, 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.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 2060444- 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T. 2822659- 02-010-01-0350 - LOGIC FEMORAL PS CEM RIGHT SZ 5. 2902685- 200-02-35 - THREE PEG PATELLA 35MM.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2014. THE PATIENT HAS SINCE REPORTED EXPERIENCING SIGNIFICANT PAIN, CLICKING OF THE KNEE, SWELLING, AND IMPAIRED MOBILITY. A RIGHT KNEE X-RAY TAKEN DURING OR AFTER A FEB 2023 DOCTOR VISIT REVEALED ¿NOTABLE POLY WEAR¿ AND ¿A LARGE AREA OF SWELLING IN THE POSTERIOR ASPECT ON THE LATERAL VIEW.¿ REVISION SURGERY WAS RECOMMENDED, HOWEVER, DUE TO THE PATIENT'S ADVANCED AGE, THEY ARE STILL CONSIDERING WHETHER THEY WILL UNDERGO AN ADDITIONAL SURGERY TO REMOVE THE IMPLANT. 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
    2077313 LOGIC TIBIA PS MOD INSRT SZ 5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. UNK 10885862001924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10