BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO 6 UNI BASEPLATE

    MDR report key: 7725209 · Received July 26, 2018

    Report

    Report Number
    3005985723-2018-00446
    Event Type
    Injury
    Date Received
    July 26, 2018
    Date of Event
    June 29, 2018
    Report Date
    July 26, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486000721
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED: "PATIENT'S LEFT MEDIAL UNI TIBIAL COMPONENT AND POLY WERE REVISED DUE TO LOOSE CEMENT. A MAKO 6 UNI BASEPLATE PART 180606 AND 6X9 POLY PART 180736-2 WERE EXPLANTED. INITIAL PROCEDURE WAS DONE AT A DIFFERENT FACILITY, NO IMPLANT RECORDS, LOTS OR PART NUMBERS AVAILABLE DUE TO NOT BEING IN THE RECORDS. NO IMPLANTS RETURNED PER HOSPITAL POLICY. AWARENESS DATE IS (B)(6) 2018. NO FURTHER INFORMATION COMING". PATIENT WAS REVISED TO A TKA WITH NAVIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565456 MAKO 6 UNI BASEPLATE PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. UNKNOWN 00848486000721

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R