BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 2820554 · Received October 26, 2012

    Report

    Report Number
    3005985723-2012-00220
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON STATED THAT HE FELT HIS CEMENTING TECHNIQUE CAUSED OR CONTRIBUTED TO THE ISSUE. THE CEMENT ADHERED TO THE IMPLANTS, BUT DID NOT ADHERE TO THE BONE. THE PATIENT DID NOT PARTICIPATE IN ANY KNOWN NON-COMPLIANT POST-OPERATIVE ACTIVITIES.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) ON (B)(6) 2012. ON THE DATE OF EVENT, THE SURGEON PERFORMED A REVISION, REPLACING THE PARTIAL KNEE COMPONENTS WITH NEW COMPONENTS OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENTAL KNEE PROSTHESIS SYSTEM NPJ MAKO SURGICAL 180505, 180605 26031111, 26201011

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention