BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 16584084 · Received March 21, 2023

    Report

    Report Number
    1038671-2023-00465
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    February 22, 2021
    Report Date
    September 13, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048318
    PMA / PMN Number
    K933610
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER CONCOMITANTS MEDICAL PRODUCTS: 1810444, 200-02-32 - THREE PEG PATELLA 32MM. .1623511, 200-04-32 - CEMENTED FINNED TIB. TRA SZ 3F/2T. 1849066, 234-02-03 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 3. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED IN THE CASE MAY HAVE BEEN THE RESULT OF POLYETHYLENE WEAR AND LOOSENING AS STATED IN THE LEGAL DOCUMENTATION AND OPERATIVE NOTES. THE ASEPTIC (NON-INFECTED) LOOSENING MAY HAVE BEEN THE RESULT OF BOTH PATIENT-RELATED CONDITIONS AND INSUFFICIENT BONDS BETWEEN THE IMPLANTS AND THE BONES. THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS, PHOTOGRAPHS, AND OPERATIVE NOTES WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT THE PATIENT, UNDERWENT INITIAL TOTAL KNEE REPLACEMENT SURGERY ON HER LEFT KNEE ON (B)(6) 2010. IN THE YEARS FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED PAIN, SWELLING, INSTABILITY, AND BONE LOSS IN HER LEFT KNEE CAUSED BY EARLY AND ACCELERATED POLYETHYLENE WEAR AND/OR COMPONENT LOOSENING. ON (B)(6) 2021, APPROXIMATELY 10 YEARS 3 MONTHS POST INITIAL PROCEDURE, PATIENT UNDERWENT AN EXTENSIVE REVISION SURGERY ON HER LEFT KNEE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361657 OPTETRAK SEE H10 JWH EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 11MM UNK 10885862048318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention SEE H10.