BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 3403304 · Received September 27, 2013

    Report

    Report Number
    3005985723-2013-00074
    Event Type
    Injury
    Date Received
    September 27, 2013
    Date of Event
    August 28, 2013
    Report Date
    August 28, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEW OF THE FEEDBACK FROM THE MAKOPLASTY SPECIALIST WHO SUPPORTED THE SURGERY, IT WAS CONCLUDED THAT THE LOOSENING OF THE PATELLA COMPONENT WAS DUE TO THE SURGEON'S MANUAL PREPARATION OF THE PATELLA I.E., SURGICAL TECHNIQUE. IT WAS ALSO CONFIRMED BY THE SURGEON AFTER HIS REVIEW OF POST-OPERATIVE X-RAYS THAT THE LOOSENING WAS DUE TO THE MANUAL CUT HE MADE ON THE PATELLA AND NOT RELATED TO THE QUALITY OF THE MAKO PRODUCT USED IN THIS SURGERY.

    Description of Event or Problem · 1

    THE PT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY, PERFORMED USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (MCK). THE SURGEON PERFORMED A ROUTINE ARTHROSCOPY TO CHECK ON KNEE PAIN THAT THE PT HAD BEEN COMPLAINING OF. THE SURGEON NOTICED THAT THE PATELLAR COMPONENT HAD DETACHED FROM THE PATELLA. THE SURGEON MANUALLY REPLACED THE PATELLAR COMPONENT, SIZING IT UP FROM A 32MM PATELLAR COMPONENT TO A 35MM PATELLAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490637 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENTAL KNEE PROSTHESIS SYSTEM NPJ MAKO SURGICAL 180320-3

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)