BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO UKR X3 ONLAY INSERT SIZE 4 - 8 MM

    MDR report key: 14753256 · Received June 21, 2022

    Report

    Report Number
    3005985723-2022-00080
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 21, 2022
    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 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK TIBIAL BASEPLATE-RM/LL-SZ 4; CAT # 180614; LOT # 26191019-01. MCK FEMORAL-RM-LL-SZ 4; CAT # 180514; LOT # 615054-M. 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

    REVISED AND PERFORMED AN I&D OF A RIGHT KNEE AND REPLACED THE TIBIAL INSERT OF AN MCK MEDIAL UNI FOR POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310463 MAKO UKR X3 ONLAY INSERT SIZE 4 - 8 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 180734-1-E J281K1 07613327385984

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Hospitalization| R