BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC KNEE COMPONENTS

    MDR report key: 21407081 · Received February 18, 2025

    Report

    Report Number
    1038671-2025-01055
    Event Type
    Injury
    Date Received
    February 18, 2025
    Report Date
    February 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. D10: (B)(6), 02-010-01-0260 - LOGIC FEMORAL PS CEM LEFT SZ 6, (B)(6), 02-012-35-6009 - LOGIC TIBIA PS MOD INSRT SZ 6 9MM, (B)(6), 02-012-45-6060 - LGC TIBIAL FIT TRAY CEM SZ 6F / 6T, (B)(6), 200-02-38 - THREE PEG PATELLA 38MM, (B)(6), 201-78-81 - 3" TROCAR, MOD. HEX 2PK, (B)(6), 201-78-81 - 3" TROCAR, MOD. HEX 2PK.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT STATED THAT THEY HAD SWOLLEN KNEES AND HAD CLICKING SOUNDS AFTER THEIR KNEE SURGERY. INFORMATION PROVIDED INDICATES THE PATIENT IS PENDING REVISION. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539869 OPTETRAK LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization SEE H11