BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTORIS MCK SYSTEM

    MDR report key: 2560563 · Received April 27, 2012

    Report

    Report Number
    3005985723-2012-00025
    Event Type
    Other
    Date Received
    April 27, 2012
    Date of Event
    March 28, 2012
    Report Date
    March 28, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVISED IMPLANTS HAVE NOT BEEN RETURNED FOR INVESTIGATION. DUE TO THE LACK OF EVIDENCE THE ROOT CAUSE OF THIS ISSUE IS STILL UNDETERMINED, ALTHOUGH THE PHYSICIAN, PT HISTORY ACCOUNT STRONGLY SUPPORTS AN INFECTION INITIATING ELSEWHERE IN THE BODY AND THEN INVOLVING THE TREATED KNEE. THERE IS NO EVIDENCE INDICATING A FAILURE OF THE IMPLANT OR THE RIO SYSTEM.

    Description of Event or Problem · 1

    THIS PT HAD A POST OPERATIVE INFECTION APPROX 8 MONTHS FROM HIS MAKOPLASTY UKA PROCEDURE (INDEX EVENT (B)(6) 2011). THIS EVENT WAS PROCEEDED BY AN UNTREATED INFECTION IS ONE OF THE PT'S THUMBS WHICH WAS FOLLOWED BY INFLAMMATION AND PAIN IN THE TREATED LEFT KNEE. FOLLOWING TREATMENT WITH SYSTEMIC ANTIBIOTICS, THE SURGEON ELECTED TO PERFORM AN INCISION AND DRAINAGE (I&D) WITH A PROPHYLACTIC SWAP OF THE LEFT KNEE TIBIAL IMPLANT POLY INSERT ON (B)(6) 2012. THE SURGERY CONCLUDED SUCCESSFULLY AND THE PT IS RECOVERING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORIS MCK SYSTEM UNINCONDYLAR KNEE SYSTEM NPJ MAKO SURGICAL 180705-1 12030611-2

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention