BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK KNEE

    MDR report key: 15020156 · Received July 14, 2022

    Report

    Report Number
    1038671-2022-00790
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    December 30, 2021
    Report Date
    February 6, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144423
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED. CONCOMITANTS: 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T; 02-010-03-0215 - LOGIC CR FEMORAL CEM, LEFT SZ 1.5; 200-02-29 - THREE PEG PATELLA 29MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS ALREADY REPORTED UNDER 1038671-2022-00722. THIS IS A DUPLICATE REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL FILING THAT A FEMALE PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 3 YEARS 8 MONTHS POST HER INITIAL LEFT KNEE TKA. INITIALLY IMPLANTED WITH AN OPTETRAK DEVICE, INCLUDING A SIZE 1.5, 13 MM OPTETRAK LOGIC TIBIAL INSERTS MADE OF POLYETHYLENE. THE PLAINTIFF WAS DIAGNOSED WITH FAILED TOTAL ARTHROPLASTY WITH EARLY POLYETHYLENE FAILURE. BEFORE THE REVISION SURGERY, SHE WAS ALSO DIAGNOSED WITH OSTEOMYELITIS IN HER KNEE DUE TO THE BREAKDOWN OF THE POLYETHYLENE. DURING THE REVISION SURGERY, THE PLAINTIFF'S SURGEON STATED, "WE WERE ABLE TO LEVER THE POLYETHYLENE PLASTIC WITH A SMALL OSTEOTOME AND AFTER THIS WAS RETRIEVED, WE THEN INSPECTED THE PLASTIC, NOTED TO HAVE PITTING AND DELAMINATION OF THE MEDIAL ASPECT OF THE TIBIAL POLYETHYLENE. OTHERWISE, THE POLYETHYLENE LOOKED TO BE IN GOOD CONDITION LATERALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350333 OPTETRAK KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. OPTETRAK KNEE UNK 10885862144423

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention