BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ 5, 11MM, SLOPE +

    MDR report key: 15393094 · Received September 9, 2022

    Report

    Report Number
    1038671-2022-01080
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    November 15, 2016
    Report Date
    May 12, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862041142
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. CONCOMITANT MEDICAL PRODUCTS; 200-02-38 - THREE PEG PATELLA 38MM 1983105, 204-04-55 - TRAPEZOID TIBIAL TRAY SZ 5F/5T 1849362, 230-02-05 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 5, 1651312.

    Additional Manufacturer Narrative · 0

    H7: Z-0019-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED (B)(6) 2011, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016, APPROXIMATELY 5 YEARS 7 MONTHS POST THE INITIAL IMPLANT PROCEDURE. THE CLAIMANT ALLEGED HE SUSTAINED INJURIES RESULTING FROM ONE OR MORE EXACTECH COMPONENTS INITIALLY IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314879 CR TIBIAL INSERT SZ 5, 11MM, SLOPE + PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. CR TIBIAL INSERT SZ 5, 11MM, SLOPE + UNK 10885862041142

    Patients

    Seq Age Sex Outcome Treatment
    1