BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK FEMORAL-RM-LL-SZ 3

    MDR report key: 24298547 · Received February 9, 2026

    Report

    Report Number
    0002249697-2026-00081
    Event Type
    Injury
    Date Received
    February 9, 2026
    Date of Event
    January 13, 2026
    Report Date
    February 9, 2026
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    HRY
    UDI-DI
    00848486000622
    PMA / PMN Number
    K242831
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A RIGHT MEDIAL MCK DUE TO FEMORAL LOOSENING. THE ORIGINAL MCK FEMORAL COMPONENT LOOSENED AND WAS ALREADY REVISED ON (B)(6) 2025. HE REVISED TO A PRIMARY TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352706 MCK FEMORAL-RM-LL-SZ 3 PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HRY MAKO SURGICAL CORP. E222-1 00848486000622

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| H