BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM

    MDR report key: 16728288 · Received April 12, 2023

    Report

    Report Number
    1038671-2023-00664
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    October 26, 2022
    Report Date
    May 21, 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
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. H3. INVESTIGATION RESULTS- THE OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM DEVICE WITH SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT'S CONDITION AND REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE. CORRECTED INFORMATION- F10, SHOULD BE BLANK.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: AA3614 13A2101 - CEMEX SYSTEM FAST GENTA 70G. 1523454 200-02-29 - THREE PEG PATELLA 29MM. 1740798 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T. 1693834 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK). 98179 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050). 1739984 244-03-02 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, RIGHT.

    Description of Event or Problem · 0

    LEGAL CASE - USA. THIS PATIENT HAD ORIGINAL RIGHT KNEE IMPLANT (B)(6) 2010. THE PATIENT RECENTLY HAD RIGHT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 12 YEARS, 4 MONTHS AFTER INITIAL IMPLANT. EBI INITIAL SURGERY - ATTACHED. (B)(4) 244-22-11 - OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM. SERIAL NUMBER 1473735 IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. PMA/510K: K033883. CONCOMITANT MEDICAL PRODUCTS: AA3614 13A2101 - CEMEX SYSTEM FAST GENTA 70G. 1523454 200-02-29 - THREE PEG PATELLA 29MM. 1740798 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T. 1693834 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK). 98179 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050). 1739984 244-03-02 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370569 OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM UNK 10885862063960

    Patients

    Seq Age Sex Outcome Treatment
    1