BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ3, 11MM

    MDR report key: 15534100 · Received October 3, 2022

    Report

    Report Number
    1038671-2022-01219
    Event Type
    Injury
    Date Received
    October 3, 2022
    Date of Event
    March 17, 2014
    Report Date
    March 9, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862040251
    PMA / PMN Number
    K932776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 200-02-29 - THREE PEG PATELLA 29MM, (B)(4), 200-04-32 - CEMENTED FINNED TIB. TRA SZ 3F/2T, (B)(4), 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050), (B)(4), 230-03-03 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3, (B)(4), CORRECTION/REMOVAL NUMBER: Z-0019-2022.

    Additional Manufacturer Narrative · 0

    H3: 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. H7: Z-0019-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL NOTIFICATION THAT AN 85 YO FEMALE PATIENT, HAD AN INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2009, AND UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014, APPROXIMATELY 5 YEARS POST OP FOR REASONS UNKNOWN. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700735 CR TIBIAL INSERT SZ3, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 200-23-11 10885862040251

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention SEE H10