BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 13450393 · Received February 4, 2022

    Report

    Report Number
    1038671-2022-00163
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    September 9, 2021
    Report Date
    July 1, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001917
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND PRE-REVISION X-RAYS WERE NOT PROVIDED. (D10) CONCOMITANT DEVICE(S): 200-02-35, 2035253 - THREE PEG PATELLA 35MM SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D4) CATALOG NUMBER: 02-012-35-4015, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 20-MAY-2017, UNIQUE IDENTIFIER (UDI) #: (B)(4). (D10) CONCOMITANT MEDICAL PRODUCTS: SEE H10. (G4) PMA/510(K)NUMBER: K033883. (H4) DEVICE MANUFACTURE DATE: 29-OCT-2009.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 10.09 YEARS SINCE INITIAL IMPLANT, THIS MALE PATIENT WITH BMI 22.7 UNDERWENT A LEFT SIDE TKA AND WAS IMPLANTED WITH AN EXACTECH UHMWPE INSERT, SERIAL # (B)(4). ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649249 OPTETRAK THREE PEG PATELLA 35MM JWH EXACTECH, INC. 200-02-35 UNK 10885862001917

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10