BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 35MM

    MDR report key: 20821886 · Received December 2, 2024

    Report

    Report Number
    1038671-2024-04564
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    November 8, 2024
    Report Date
    August 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039606
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: A10012 - GPS IMPLANT KIT V2 11021019275 02-020-13-0240 - TRULIANT CR CEM FEM CR CEM LEFT SZ 4, (B)(6). 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, (B)(6). 02-022-45-4030 - TRULIANT TIB FIT TRAY CEM SZ 4F / 3T, (B)(6). 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK, (B)(6). 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK, (B)(6). 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK, (B)(6).

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT WAS REVISED DUE TO PAIN. THE PATELLA WAS REMOVED AND REPLACED WITH A COMPETITORS PATELLA. A NEW 12MM CRC VIT E INSERT WAS ALSO PLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327025 THREE PEG PATELLA 35MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization SEE H11.