BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    KLASSIC SOMBRERO PATELLA WITH E-LINK

    MDR report key: 24003890 · Received January 8, 2026

    Report

    Report Number
    3008544874-2026-00001
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    December 4, 2025
    Report Date
    January 7, 2026
    Manufacturer
    TOTAL JOINT ORTHOPEDICS, INC.
    Product Code
    JWH
    UDI-DI
    00814703014826
    PMA / PMN Number
    K180159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOST LIKELY CAUSE OF THIS FAILURE IS A RESULT OF A FALL THAT THE PATIENT HAD WHICH RESULTED IN THE PREMATURE FAILURE OF THE PATELLA IMPLANT. THERE IS NO IDENTIFIED CONCERN REGARDING THE IMPLANT ITSELF OR THE INITIAL SURGICAL IMPLANTATION.

    Description of Event or Problem · 0

    PATIENT REQUIRED REVISION SURGERY TO CORRECT A PATELLA IMPLANT THAT THE PEGS SHEARED OFF AFTER 2 YEARS OF USE. CEMENT WAS BONDED WELL TO BOTH BONE AND IMPLANT. PATIENT REPORTED PAIN A FEW MONTHS AGO, XRAYS SHOWED NOTHING. SHE WENT BACK TO THE CLINIC ON WEDNESDAY (B)(6) 2025 AND IT WAS CLEAR THE IMPLANT WAS OFF THE BONE AND FLOATING. THE PEGS WERE STUCK AND WERE REMOVED WITH CURETTES AND RONGUER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66418 KLASSIC SOMBRERO PATELLA WITH E-LINK PATELLA IMPLANT JWH TOTAL JOINT ORTHOPEDICS, INC. OPABD02 00814703014826

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention