BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 3779149 · Received April 15, 2014

    Report

    Report Number
    3005985723-2014-00039
    Event Type
    Injury
    Date Received
    April 15, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVAL OF THE EVENT HAS BEEN CONDUCTED BY MAKO SURGICAL. THE SURGEON STATED THAT THE INFECTION HAD NOTHING TO DO WITH THE IMPLANTS. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION TO ENSURE COMPLIANCE TO THE MDR REGULATION AN DIS BASED ON THE INCISION AND DRAINAGE PROCEDURE PERFORMED TO ADDRESS THE INFECTION. NO EVIDENCE SUGGESTS THAT THE INFECTION WAS DUE TO ANY MAKO PRODUCT.

    Description of Event or Problem · 1

    A SURGEON INFORMED MAKO SURGICAL ON (B)(6) 2014 THAT HE MAY HAVE TO REVISE A PT WHO UNDERWENT A PARTIAL KNEE ARTHROPLASTY CASE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE IMPLANTS ON (B)(6) 2014. DUE TO AN INFECTION OF THE JOINT, THE SURGEON PERFORMED AN INCISION AND DRAINAGE PROCEDURE. THE SURGEON PERFORMED AN INCISION AND DRAINAGE PROCEDURE AND EXCHANGED THE ONLAY INSERT COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230906 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS NPJ MAKO SURGICAL 180705-1 12040413-1

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)