BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 3, 18MM

    MDR report key: 19466379 · Received June 5, 2024

    Report

    Report Number
    1038671-2024-01740
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    November 2, 2022
    Report Date
    June 5, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054289
    PMA / PMN Number
    K954208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 4855763, 02-012-60-1880 - TRU STEM EXT 18MM X 80MM. 4872092, 02-012-60-2080 - TRU STEM EXT 20MM X 80MM. 4883663, 200-02-38 - THREE PEG PATELLA 38MM. 4938129, 208-01-03 - CC FEMORAL SZ 3. 4939371, 204-04-33 - TRAPEZOID TIBIAL TRAY SZ 3F/3T. 5023100, 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS THE CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 60 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DISCOMFORT, AND DIFFICULTY WALKING. PLAINTIFF HAS SUFFERED, AND MAY CONTINUE TO SUFFER, SEVERE AND PERMANENT PERSONAL INJURIES, INCLUDING POLYETHYLENE WEAR AND DEVICE FAILURE, PAINFUL KNEE REVISION SURGERY TO REMOVE OR REVISE THE DEFECTIVE DEVICE, CONTINUED REHABILITATION, MEDICAL CARE, AND POSSIBLE ADDITIONAL SURGERIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859798 CC TIBIAL INSERT SZ 3, 18MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862054289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R