BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM

    MDR report key: 9829417 · Received March 13, 2020

    Report

    Report Number
    3005985723-2020-00151
    Event Type
    Injury
    Date Received
    March 13, 2020
    Date of Event
    February 14, 2020
    Report Date
    March 13, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486016494
    PMA / PMN Number
    K150307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 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: 1142407,180505, MCK FEMORAL-LM-RL-SZ 5, OFL; CAT# 180505; LOT# 563972-M. 1142415,180604,MCK TIBIAL BASEPLATE-LM/RL-SZ 4,OFL; CAT# 180604; LOT# 26120518-01. 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

    IT WAS REPORTED THAT THE PATIENT'S RIGHT LATERAL PKA WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED. REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291768 MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 180734-1 718OTD 00848486016494

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R