BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 3190895 · Received June 20, 2013

    Report

    Report Number
    3005985723-2013-00036
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    October 25, 2012
    Report Date
    May 21, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT F/U, AN EVAL WAS INITIATED BY MAKO SURGICAL WITH REGARD TO THIS EVENT. THE EVAL IS IN PROGRESS, AND NO PRELIMINARY INFO IS CURRENTLY AVAILABLE. THE PT WAS CONTACTED BY MAKO SURGICAL CORP. TO COMMUNICATE THAT THE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    MAKO RECEIVED A LETTER FROM A PT. HE INDICATED HE HAD A LEFT MEDIAL MAKOPLASTY PARTIAL KNEE ARTHROPLASTY PROCEDURE SIX AND A HALF MONTHS AGO AND WAS NOT EXPERIENCING GOOD RESULTS. HE COMPLAINED OF A PATELLAR CYST AND "GLOBAL KNEE PAIN, MUSCULAR ACHING, CRAMPING, STIFFNESS, LIMITED FLEXION AND STILL SOME HEAT AND SWELLING OF THE KNEE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280771 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENTAL KNEE PROSTHESIS SYSTEM NPJ MAKO SURGICAL 180506 26150312-022

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)| LOT# LET1411840512| ONLAY TIBIAL BASEPLATE: MODEL# 180606,