BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK KNEE COMPONENT - TIBIAL INSERT

    MDR report key: 19570438 · Received June 19, 2024

    Report

    Report Number
    1038671-2024-02012
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    June 16, 2023
    Report Date
    June 19, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    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: 4842502 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T. 4926850 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T. 2997855 02-012-51-2513 - LOGIC TIB INSERT IMPL CRC, SZ 2.5, 13MM. 2659595 02-012-51-2515 - LOGIC TIB INSERT IMPL CRC, SZ 2.5, 15MM. 4909306 02-020-13-0225 - TRULIANT CR CEM FEM CR CEM LEFT SZ 2.5. 5018716 02-020-13-0325 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 2.5. 4867570 200-07-29 - ADVANCED PATELLA 29M 3 PEG IMPLANT. 4959250 200-07-29 - ADVANCED PATELLA 29M 3 PEG IMPLANT. 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 68 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672833 OPTETRAK KNEE COMPONENT - TIBIAL INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11