BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 5, 11MM

    MDR report key: 16859538 · Received May 3, 2023

    Report

    Report Number
    1038671-2023-00887
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    April 4, 2022
    Report Date
    September 25, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054418
    PMA / PMN Number
    K954208
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 510K: PER ACCESSGUDID.NLM.NIH.GOV, DEVICE IS EXEMPT FROM PREMARKET SUBMISSION / PRO CODE PER ACCESSGUDID.NLM.NIH.GOV IS HWT. INVESTIGATION: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    D10. OPTETRAK CEMENTED TRAPEZOID TIBIAL TRAY (204-04-55; SN (B)(6)). OPTETRAK FEMORAL AND TIBIAL FLUTED STEM (204-32-01; SN (B)(6)). OPTETRAK 3 PEG PATELLA (200-02-38; SN (B)(6)). OPTETRAK NMC (210-01-05; SN (B)(6)). H3. INVESTIGATION RESULTS-THE OPTETRAK NCMC CONDYLAR TIBIAL INSERT DEVICE WITH SN (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT¿S INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS [CHRONIC KIDNEY DISEASE AND HYPERTENSION] , UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    PER A REPORT FROM THE LEGAL DEPARTMENT THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2005. APPROXIMATELY 16 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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.

    Description of Event or Problem · 0

    REVISION OPERATIVE REPORT OF (B)(6) 2022- THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A 3-DAY HISTORY OF SEVERE RIGHT KNEE PAIN AND SWELLING. A RIGHT KNEE ASPIRATION WAS PERFORMED REVEALING GROUP B STREPTOCOCCUS INFECTION AND ELEVATED CELL COUNT. GIVEN THESE FINDINGS, THE PATIENT WAS DIAGNOSED WITH A RIGHT KNEE PERIPROSTHETIC JOINT INFECTION. PREOPERATIVE DIAGNOSIS: RIGHT KNEE PERIPROSTHETIC JOINT INFECTION. INTRAOPERATIVE FINDINGS: INTRAOPERATIVELY THE KNEE WAS NOTED TO HAVE PURULENT APPEARING SYNOVIAL FLUID WHICH WAS ASPIRATED AT THE BEGINNING OF THE CASE. THE PATIENT HAD EXTENSIVE SYNOVITIS. THERE IS SCARRING ALONG THE ANTERIOR ASPECT OF THE FEMUR. ON INITIAL STABILITY TESTING THE MEDIAL COLLATERAL LIGAMENTS APPEARED LAX. THERE IS NO OSTEOMYELITIC BONE. THE PATELLAR BUTTON, TIBIAL COMPONENT, AND FEMORAL COMPONENT WERE WELL FIXED. FOLLOWING REMOVAL OF THE TIBIA AND FEMORAL COMPONENTS AS WELL AS THE PATELLA BUTTON THERE WAS GOOD BONE STOCK. THE MEDIAL AND LATERAL FEMORAL CONDYLES WERE INTACT. THE PATIENT WOKE FROM ANESTHESIA WITHOUT COMPLICATION/ TRANSFERRED TO POST ANESTHESIA CARE UNIT IN STABLE CONDITION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800430 CC TIBIAL INSERT SZ 5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. 205-25-11 UNK 10885862054418

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention SEE H10