BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 9 MM

    MDR report key: 7830556 · Received August 29, 2018

    Report

    Report Number
    3005985723-2018-00515
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    August 1, 2018
    Report Date
    August 29, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486016555
    PMA / PMN Number
    K150307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT OR STERILE LOT REFERENCED. 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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 3; CAT# 180513; LOT# 515158-M. MCK TIBIAL BASEPLATE-RM/LL-SZ 5; CAT# 180615; LOT# 26311116-01. 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 · 1

    SURGEON REVISED A MAKO TIBIAL INSERT ORIGINALLY IMPLANTED ON (B)(6) 2018 DUE TO INFECTION, PERFORMING AN I&D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670521 MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 9 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. RV6L49 00848486016555

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R