BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 17001484 · Received May 25, 2023

    Report

    Report Number
    1038671-2023-01138
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    April 9, 2018
    Report Date
    March 24, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054166
    PMA / PMN Number
    K954208
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED MAY HAVE BEEN DUE TO THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, AND/OR MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, WHICH LED TO PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICE/RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITTANTS: 02-012-45-3030 - BANDEJA TIBIAL LOGIC FIT 3F/3T 3928455. 232-03-03 - COMP. FEMORAL ASIMETRICO POROSO CR Nº3 DCHA 3882831. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN INPERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT ((B)(6)) WAS IMPLANTED WITH A 208-22-09-INSERTO TIBIAL CC 2,9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2013. THE INSERT WAS MANUFACTURED ON 12/12/2011 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 12/12/2011 AND WAS 1.19 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON( B)(6) 2018, APPROXIMATELY 5.0 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698262 OPTETRAK SEE H10 JWH EXACTECH, INC. CC TIBIAL INSERT SZ 2, 9MM UNK 10885862054166

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention