BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 38MM

    MDR report key: 19935358 · Received August 7, 2024

    Report

    Report Number
    1038671-2024-02738
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 18, 2024
    Report Date
    November 20, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039613
    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

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 5452995 , 02-010-01-0230 - LGC FEMORAL PS CEM LEFT SZ 3. (B)(6) , 02-012-38-3011 - LGC TIBIA PS RBK INSRT SZ 3 11MM. THE SERIAL NUMBER (B)(6) IS NOT AFFECTED BY THE RECALL. 5896386, 02-012-43-3040 - LGC TIBIA RBKTRAY CEM SZ 3F/ 4T. 329258, 203-90-01 - 11-2624 POWERPRO SAWBLADE. 332358, 203-90-22 - (3118) HALL PWR PRO/VERS PWR PLUS 90X19X1.19MM.

    Additional Manufacturer Narrative · 0

    (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE PATELLA COMPONENT. THE CAUSE OF THE PROSTHESIS WEAR CANNOT BE DETERMINED BECAUSE THE REVISED COMPONENTS WERE NOT RETURNED FOR EVALUATION AND NO RADIOGRAPHS WERE PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 62 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 4 YEARS POST OP. THE REVISION WAS DUE TO PATELLA POLY WEAR. EVERYTHING WAS REMOVED AND EXCHANGED TO A COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING -DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426037 THREE PEG PATELLA 38MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention SEE H11.