BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 3021500 · Received March 7, 2013

    Report

    Report Number
    3005985723-2013-00011
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 12, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    HRY
    PMA / PMN Number
    P090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. THE SURGEON STATED THAT THE PATIENT IS DOING FINE AND ONCE THE INFECTION HAD SUBSIDED THAT HE WOULD REPLACE THE ANTIBIOTIC SPACER WITH A MAKO ONLAY INSERT COMPONENT. THE SURGEON CONCLUDED THAT THE INFECTION DID NOT RESULT FROM THE ORIGINAL MAKOPLASTY PROCEDURE OR THE IMPLANTS.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A MAKOPLASTY PARTIAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2012. THE PATIENT PRESENTED WITH A POST-OPERATIVE INFECTION, AND THE SURGEON REPLACED THE ONLAY INSERT COMPONENT WITH AN ANTIBIOTIC SPACER ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98634 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENTAL KNEE PROISTHESIS SYSTEM HRY MAKO SURGICAL 180702-1 12080312-2

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention