BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK PATELLOFEMORAL-L-SZ 3

    MDR report key: 10959592 · Received December 7, 2020

    Report

    Report Number
    3005985723-2020-00380
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    November 11, 2020
    Report Date
    December 7, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486000417
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK PATELLA RESURFACING ROUND DOME-32MM;180320-3; 12050417-1. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    DR. REVISED A LEFT MAKO PATELLOFEMORAL TO A MAKO TRIATHLON TOTAL KNEE DUE TO PAIN. ORIGINAL PF WAS DONE ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423338 MCK PATELLOFEMORAL-L-SZ 3 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY NPJ MAKO SURGICAL CORP. 180403 UNKNOWN 00848486000417

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R