BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 29MM

    MDR report key: 20096629 · Received August 29, 2024

    Report

    Report Number
    1038671-2024-03169
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    November 23, 2023
    Report Date
    October 18, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: LOGIC CR FEMORAL POR, LEFT, SZ 5 - 02-010-04-0250 - 6265790. LGC TIBIAL FIT TRAY CEM SZ.5F / 5T - 02-012-45-5050 - 6705617.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF PROSTHESIS WEAR AND FEMORAL LOOSENING. THE WEAR AND/OR DEFORMATION OF THE TIBIAL INSERT AND PATELLA MAY HAVE BEEN THE RESULT OF THIRD BODY WEAR, ORIENTATION OF THE COMPONENTS, PATIENT RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING OF THE FEMORAL COMPONENT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN PREVIOUS REVISION ON (B)(6) 2023. THE PATIENT WAS REVISED AGAIN ON (B)(6) 2023 DUE TO PATELLA WEAR AND POLY WEAR; THERE WAS NO CHANGE IN SIZING. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313720 THREE PEG PATELLA 29MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention SEE H11