BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO UKR X3 ONLAY INSERT SIZE 4 - 8 MM

    MDR report key: 25135312 · Received May 11, 2026

    Report

    Report Number
    3005985723-2026-00231
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 11, 2026
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    07613327385984
    PMA / PMN Number
    K180612
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT# 180614; MCK TIBIAL BASEPLATE-RM/LL-SZ 4; LOT# J61528. CAT# 180514; 180514 MCK FEMORAL-RM-LL-SZ 4; LOT# G65D-1. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED: DR. MARCHAND PERFORMED AN I&D OF A RIGHT MEDIAL MCK KNEE DUE TO INFECTION AND SWAPPED THE INSERT. ORIGINAL SURGERY WAS (B)(6) 26 AT ORI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490081 MAKO UKR X3 ONLAY INSERT SIZE 4 - 8 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 9M2J6Y 07613327385984

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| H