BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 2622298 · Received June 12, 2012

    Report

    Report Number
    3005985723-2012-00168
    Event Type
    Injury
    Date Received
    June 12, 2012
    Date of Event
    May 13, 2012
    Report Date
    May 15, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN INVESTIGATION WAS PERFORMED AT MAKO SURGICAL WITH REGARDS TO THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC (RIO) AND RESTORIS MCK. DURING THE PROCEDURE THE SURGEON MADE THE SUGGESTION TO THE PT THAT HE WOULD BENEFIT MORE FROM A TOTAL KNEE ARTHROPLASTY, HOWEVER THE PT INSISTED ON RECEIVING THE PARTIAL KNEE REPLACEMENT. THE PT WAS HIGHLY ACTIVE AFTER SURGERY AND THUS NON-COMPLIANT TO POST-SURGERY PROTOCOL. THIS LIKELY CONTRIBUTED TO THE SURGEON'S FINDING OF LOOSE CARTILAGE FRAGMENTS IN THE PT'S JOINT. THE SURGEON DID NOT BELIEVE THAT THE RIO OR THE MCK IMPLANT SYSTEM CAUSED OR CONTRIBUTED TO THE NEED FOR THE REVISION.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A RIGHT MEDIAL UNILATERAL PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (MCK) ON (B)(6) 2011. MAKO SURGICAL WAS MADE AWARE ON (B)(6) 2012, THAT A PT HAD A POST-OPERATIVE INFECTION AFTER HAVING A MAKOPLASTY UNICONDYLAR KNEE REPLACEMENT USING RESTORIS MCK. THE SURGEON ELECTED TO PERFORM AN INCISION AND DRAINAGE PROCEDURE (KNOWN AS AN I AND D) AND EXCHANGED THE RESTORIS MCK POLYETHYLENE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM UNICONDYLAR KNEE NPJ MAKO SURGICAL 180706-2 12130711-3

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention