BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 2981095 · Received February 21, 2013

    Report

    Report Number
    3005985723-2013-00008
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    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 EVALUATION WAS INITIATED BY MAKO SURGICAL WITH REGARD TO THIS EVENT. SURGEONS OFTEN CHOOSE TO EXCHANGE THE POLY COMPONENT DURING ROUTINE PROCEDURES UNRELATED TO THE ORIGINAL MAKOPLASTY EVENT. THIS HAS BEEN SEEN MOST COMMONLY WITH SURGEONS OPENING THE JOINT TO PERFORM AN I AND D PROCEDURE TO REMOVE OR PROACTIVELY TREAT INFECTION. NO OTHER INCIDENTS WERE REPORTED FROM THIS CASE RELATED TO THE IMPLANTS OR PROCEDURE AND THERE WERE NO INDICATIONS OF IMPLANT OR PROCEDURE-RELATED FAILURES REPORTED. IT IS STANDARD PRACTICE TO EXCHANGE THE IMPLANT POLY TO REMOVE ANY POSSIBLE INFECTIONS MATERIALS ON IT.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A RIGHT ONLAY LATERAL PROCEDURE ON (B)(6) 2012. AFTER APPROXIMATELY 3 WEEKS, THE PATIENT ALLEGED PAIN AND A FEVER AND THE KNEE APPEARED TO BE INFECTED. THE SURGEON ASPIRATED THE KNEE ON (B)(6) 2013 AND REPORTED THAT THE CULTURE SAMPLES WERE NEGATIVE. ON (B)(6) 2013, THE SURGEON PERFORMED INCISION AND DRAINAGE PROCEDURE AND REPLACED THE ONLAY INSERT. CULTURE RESULTS COLLECTED ON (B)(6) 2013 TESTED POSITIVE FOR A STAPH INFECTION. THE SURGEON HAS INDICATED THAT HE HAS NOT MADE ANY PLANS TO REVISE THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75110 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENTAL KNEE PROSTHESIS SYSTEM NPJ MAKO SURGICAL 180706-1 12100712-1

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)