BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 16988863 · Received May 23, 2023

    Report

    Report Number
    1038671-2023-01096
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    April 28, 2023
    Report Date
    April 8, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862063960
    PMA / PMN Number
    K033883
    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

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITTANTS: 204-04-23 - BANDEJA TIB QUILLA TRAP CEMENTADA 1F/3T, 2F/3T 2095551. 204-34-04 - VASTAGO EXT. 14X40MM 1903080. 204-70-00 - TORNILLO FIJACION VÁSTAGO A TIBIA 2149142. 244-02-02 - COMP. FEMORAL ASIMETRICO CEMENTADO HF PS Nº2 IZQ. 2073378. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: THE PROSTHESIS WEAR REPORTED MAY HAVE BEEN DUE TO THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, AND/OR BEING IMPLANTED FOR OVER 11 YEARS. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED.

    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 244-22-11-INSERTO TIB PS HI-FLEX 2, 11MM, SERIAL NUMBER (B)(6) ON (B)(6)2012. THE INSERT WAS MANUFACTURED ON 2/4/2011 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 2/4/2011 AND WAS 0.95550992470910334 YEARS SHELF AGE AT THE TIME OF IMPLANT. PENDING 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
    1450392 OPTETRAK SEE H10 JWH EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM UNK 10885862063960

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other