BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 2, 9MM

    MDR report key: 16704245 · Received April 7, 2023

    Report

    Report Number
    1038671-2023-00624
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    August 22, 2022
    Report Date
    September 11, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K954208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION CONCOMITANT MEDICAL PRODUCTS: SERIAL#: (B)(4), CATEGORY#: 203-90-01 - 11-2624 POWERPRO SAWBLADE, SERIAL#: (B)(4), CATEGORY#: 204-04-23 - TRAPEZOID TIBIAL TRAY SZ 1F/3T, 2F/3T, SERIAL#: (B)(4), CATEGORY#: 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM, SERIAL#: (B)(4), CATEGORY#: 200-02-32 - THREE PEG PATELLA 32MM, SERIAL#: (B)(4), CATEGORY#: 201-78-11 - HOLDING PIN SMALL HEADED SHORT 4 PACK, SERIAL#: (B)(4), CATEGORY#: 210-01-02 - NMC FEMORAL SZ 2, SERIAL#: (B)(4), CATEGORY#: 13A2101 - CEMEX SYSTEM FAST GENTA 70G.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION:THE REVISION REPORTED IN THE CASE MAY HAVE BEEN THE RESULT OF POLYETHYLENE WEAR AND FEMORAL LOOSENING AFTER BEING IMPLANTED FOR OVER 10 YEARS AS STATED IN THE INFORMATION PROVIDED. THE ASEPTIC (NON-INFECTED) FEMORAL LOOSENING MAY HAVE BEEN THE RESULT OF BOTH PATIENT-RELATED CONDITIONS AND A DEGRADATION OF THE BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE. THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS, AND PHOTOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    LEGAL CASE: (B)(6). AS REPORTED VIA LEGAL DOCUMENT, POST-PROCEDURE DIAGNOSIS: LEFT TKA ASEPTIC LOOSENING, LEFT TKA POLYETHYLENE BEARING WEAR, PATIENT WAS AWOKEN FROM ANESTHESIA AND TRANSFERRED TO THE POSTANESTHESIA CARE UNIT IN STABLE CONDITION WITH STABLE VITAL SIGNS HAVING TOLERATED THE PROCEDURE WELL WITHOUT APPARENT COMPLICATIONS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL#: (B)(4), CATEGORY#: 208-22-09 - CC TIBIAL INSERT SZ 2, 9MM, SERIAL NUMBER: (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K954208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441464 CC TIBIAL INSERT SZ 2, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. CC TIBIAL INSERT SZ 2, 9MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention