BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3

    MDR report key: 16637156 · Received March 29, 2023

    Report

    Report Number
    1038671-2023-00539
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    November 13, 2012
    Report Date
    March 29, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862061751
    PMA / PMN Number
    K032606
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 1395572 200-73-13 - CR TIBIAL INSERT SZ 3, 13MM, SLOPE ++ 1707117 200-02-29 - THREE PEG PATELLA 29MM 2022091 204-04-33 - TRAPEZOID TIBIAL TRAY SZ 3F/3T. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THE PATIENT HAS BILATERAL KNEE REPLACEMENTS. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTS THAT ON (B)(6), 2011 A FEMALE PATIENT UNDERWENT AN INITIAL RIGHT KNEE TOTAL ARTHROPLASTY, THEN ON (B)(6), 2012, THE PATIENT UNDERWENT A REVISION OF THE EXACTECH CONSTRAINED CONDYLAR FEMORAL COMPONENT APPROXIMATELY 1 YEAR 5 MONTHS AFTER IMPLANT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714595 OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3 SEE H10 JWH EXACTECH, INC. 230-03-03 10885862061751

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention