BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 15MM

    MDR report key: 23827385 · Received December 17, 2025

    Report

    Report Number
    1038671-2025-03571
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 12, 2024
    Report Date
    May 20, 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

    D10: C040140G - ORTHOCEM G1 STANDARD VISCOSITY CEMENT. 204-63-05 - TIBIAL AUGMENT BLOCK 1/2-SZ 3 5MM. 200-02-35 - THREE PEG PATELLA 35MM. 204-63-05 - TIBIAL AUGMENT BLOCK 1/2-SZ 3 5MM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED, THE IMPLANT FAILED CLINICALLY, RESULTING IN MAJOR BONE OSTEOLYSIS AND NECESSITATING REVISION SURGERY. EVERYTHING WAS FINE UNTIL ABOUT 1.5 YEARS AGO WHEN PAIN, EFFUSION AND DECREASED MOBILITY BEGAN. X-RAY SHOWING OSTEOLYSIS OF THE POSTERIOR CONDYLES; COMPARING THIS X-RAY WITH THE ONE FROM 2019, DEGENERATION IS EVIDENT. RADIOLUCENT LINES ARE SEEN SURROUNDING BOTH COMPONENTS, WHICH SHOULD BE EVALUATED CLINICALLY (POSSIBLE LOOSENING?). BONE BIOPSIES AND MICROBIOLOGICAL AND HISTOLOGICAL STUDIES RULE OUT INFECTION. INFECTIOUS COMPLICATION; FALL; PRESSURE ULCER; SURGICAL WOUND INFLAMMATION; REINTERVENTION. REMOVAL OF PTJ DTA WITH FINDINGS OF EXTENSIVE SYNOVITIS AND MASSIVE TIBIAL AND FEMORAL OSTEOLYSIS AND REVISION ARTHROPLASTY WITH CEMENTED TIBIA AND FEMORAL SLEEVE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE. THE PATIENT SUFFERED PERMANENT DISABILITY AS DIRECT RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335807 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