BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM

    MDR report key: 8860012 · Received August 5, 2019

    Report

    Report Number
    3005985723-2019-00553
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    July 9, 2019
    Report Date
    August 5, 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

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 4; CAT# 180514; LOT# 563346-M; MCK TIBIAL BASEPLATE-RM/LL-SZ 5; CAT# 180615; LOT# 26021018-01. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    DR. PERFORMED AN I&D WITH POLY EXCHANGE ON A MAKO MEDIAL UNI KNEE ORIGINALLY DONE ON (B)(6) 2019. DUE TO INFECTION. NO ISSUES WITH THE COMPONENT WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654774 MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. DL014H 00848486016548

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R