BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 35MM

    MDR report key: 20067254 · Received August 26, 2024

    Report

    Report Number
    1038671-2024-03076
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    April 22, 2024
    Report Date
    September 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039606
    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: THE REVISION REPORTED WAS LIKELY THE RESULT OF PRESUMED WEAR OF THE TIBIAL INSERT AND PATELLA. HOWEVER, IMAGES OF THE REVISED INSERT AND PATELLA DO NOT SHOW SIGNS OF EXCESSIVE PROSTHESIS WEAR INCONSISTENT WITH BEING IMPLANTED.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 6309402 - 02-012-38-2509 - LOGIC RBK INSERT SZ 2.5, 9MM. 6312520 - 02-010-01-0225 - LGC FEMORAL PS CEM LEFT SZ 2.5. 6281223 - 02-012-43-2525 - LGC TIBIA RBKTRAY CEM SZ 2.5F/2.5T. 6454830 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 6167773 - 201-78-81 - 3 TROCAR, MOD. HEX 2PK. S040467 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S040716 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S049580 - 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS. 1021420158 - A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 65 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 4 YEARS POST OP. THE PATIENT SUFFERED FROM PATELLA WEAR, TIBIAL INSERT WEAR/PITTING, FEMORAL DELAMINATION. EVERYTHING WAS REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246027 THREE PEG PATELLA 35MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039606

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention SEE H11.