BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T

    MDR report key: 21161427 · Received January 15, 2025

    Report

    Report Number
    1038671-2025-00268
    Event Type
    Injury
    Date Received
    January 15, 2025
    Date of Event
    October 7, 2024
    Report Date
    March 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862003997
    PMA / PMN Number
    K101981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION: PLEASE DISREGARD THIS REPORT AS IT WAS SUBMITTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT # 1038671-2025-00376.

    Additional Manufacturer Narrative · 0

    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. CONCOMITANTS: (B)(6), 02-012-35-3509 LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM; (B)(6), 200-02-32 THREE PEG PATELLA 32MM; (B)(6), 02-010-01-0235 - FEMUR PS CEM.Nº3.5 IZQ.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS AND 10 MONTHS POST INITIAL TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT EXPERIENCED PAIN IN THE OPERATED KNEE. DURING EXAMINATION, THE PATIENT HAD MULTIDIRECTIONAL INSTABILITY OF THE KNEE. IN RADIOLOGICAL STUDY, THE IMAGE WAS COMPATIBLE WITH POLYETHYLENE WEAR, WEAR OF THE PATELLAR COMPONENT, MASSIVE OSTEOLYSIS IN RELATION TO THE TIBIAL COMPONENT, AND TESTS COMPATIBLE WITH ASEPTIC DISIMPLANTATION. THE PATIENT HAD NORMAL BLOOD METAL LEVELS. IT WAS FURTHER NOTED THAT THE PATIENT EXPERIENCED SIGNIFICANT DISABILITY AND SURGICAL REVISION WAS PERFORMED TO AVOID INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300273 OPTETRAK LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862003997

    Patients

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