BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAKO RESTORIS MCK FEMORAL COMPONENT SIZE 2

    MDR report key: 22139534 · Received June 4, 2025

    Report

    Report Number
    3005985723-2025-00249
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    May 13, 2025
    Report Date
    June 4, 2025
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PT. REPORTED; IN (B)(6) 2019, I HAD A PARTIAL KNEE REPLACEMENT USING STRYKER MAKO PRODUCTS AND ENDED UP IN EARLY 2024 HAVING LOTS OF PROBLEMS WITH IT. REVISED ON (B)(6) 2025 TO A FULL KNEE REPLACEMENT. BUT WHEN THE SURGEON WENT IN, HE DID FIND THE MEDIAL MOST SIDE OF THE FEMORAL RUNNER WAS PROMINENT AND HAD WORN LONGITUDINAL RIDGE IN THE MEDIAL TIBIAL POLYETHYLENE AND THERE WAS LOTS OF PLASTIC FLAKING IN THERE DUE TO THAT WEAR. SO THAT WAS CAUSING A LOT OF IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673546 UNKNOWN MAKO RESTORIS MCK FEMORAL COMPONENT SIZE 2 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H