BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM

    MDR report key: 8274354 · Received January 24, 2019

    Report

    Report Number
    3005985723-2019-00072
    Event Type
    Injury
    Date Received
    January 24, 2019
    Date of Event
    December 28, 2018
    Report Date
    January 24, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486016548
    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 PRODUCT HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER 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-LM/RL-SZ 5, CAT#180605, LOT#26470917-01. MCK FEMORAL-LM-RL-SZ 5, CAT#180505, LOT#549084-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 · 1

    I&D WITH A TIBIAL INSERT EXCHANGE PERFORMED ON (B)(6) 2018 OF A MAKO PKA ORIGINALLY DONE ON (B)(6) 2018 DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67323 MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 1W557X 00848486016548

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R