BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 15MM

    MDR report key: 23810944 · Received December 15, 2025

    Report

    Report Number
    1038671-2025-03550
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    May 23, 2018
    Report Date
    March 23, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862064066
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4, D10, G4, H4, H6 THE FOLLOWING SECTIONS WERE CORRECTED: D1, D10: 204-63-05 - TIBIAL AUGMENT BLOCK 1/2-SZ 3 5MM 3574021, 204-04-43 - TRAPEZOID TIBIAL TRAY SZ 4F/3T 4F/3T 3710427, 204-63-05 - TIBIAL AUGMENT BLOCK 1/2-SZ 3 5MM 4654381, 200-02-35 - THREE PEG PATELLA 35MM 5157978, 244-03-04 - OPTETRAK ASY, HI-FLEX PS CEM FEM, SZ 4, RIGHT 5295836.

    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.

    Description of Event or Problem · 0

    AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED SEPTIC ARTHRITIS OF THE RIGHT KNEE TO THE UPPER LIMBS WITH PAIN AND STIFFNESS. THE PATIENT UNDERWENT PERCUTANEOUS TRANSTRACHEAL JET VENTILATION (PTJV) IN 2T REQUIRING DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION (DAIR) POST-OP. THE PATIENT TOOK ANTIBIOTICS TO TREAT THEIR BIOFILM FOR SIX MONTHS AND IT WENT WELL. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155394 OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862064066

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention| H SEE H11.