BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 3221067 · Received July 2, 2013

    Report

    Report Number
    3005985723-2013-00043
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE EVENT HAS BEEN PERFORMED AT MAKO SURGICAL. INVESTIGATION OF THE IMPLANT'S SURFACE DID NOT SHOW SIGNS OF ADVANCED WEAR. POLISHING AND SOME SLIGHT PITTING WAS SEEN ALONG THE LINE OF ARTICULATION WITH THE FEMORAL COMPONENT. PEER-REVIEWED ARTICLES IN THE LITERATURE SUGGEST THAT POLYETHYLENE WEAR RARELY LEADS TO INFECTION. THE ROOT CAUSE OF THE PATIENT'S INFECTION IS UNK. HOWEVER, THE SURGEON STATED THAT THE PATIENT IS AN AVID BIKE RIDER AND WAS VERY AGGRESSIVE IN HIS RECOVERY. AN I& D PROCEDURE FOLLOWED BY A SWAP OF THE TIBIAL INSERT IS CONSIDERED ROUTINE AND COMMON TO TREAT AN INFECTION. THE PATIENT IS EXPECTED TO MAKE A COMPLETE RECOVERY.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (MCK) ON (B)(6) 2013. THE PATIENT'S KNEE BECAME INFECTED AND THE SURGEON PERFORMED AN INCISION AND DRAINAGE (I&D) PROCEDURE AND EXCHANGED THE TIBIAL INSERT FOR A NEW ONE. THE IMPLANTS LOOKED TO BE WELL-ALIGNED AND BALANCED ON THE X-RAYS, AND THE SURGEON WAS SATISFIED WITH THE CLINICAL ASSESSMENT OF THE KNEE INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300329 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENTAL KNEE PROSTHESIS SYSTEM NPJ MAKO SURGICAL CORP. 180703-2 12090910

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention