BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MCK

    MDR report key: 2252759 · Received August 12, 2011

    Report

    Report Number
    3005985723-2011-00021
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MAKO SURGICAL
    Product Code
    HSX
    PMA / PMN Number
    K082172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVISED IMPLANTS WERE NOT RETURNED FOR INVESTIGATION. MAKO REQUESTED THE POST-OP X-RAYS FOR RECORD REVIEW. THE SURGEON STATED THAT THE IMPLANTS WERE POSITIONED PROPERLY AND NO COMPONENTS WERE LOOSE. DUE TO THE LACK OF EVIDENCE AND THAT THE X-RAYS HAVE NOT YET BEEN REVIEWED, THE ROOT CAUSE OF THE ISSUE IS STILL UNDETERMINED. THERE IS NO EVIDENCE INDICATING A FAILURE OF THE IMPLANT OR THE RIO SYSTEM.

    Description of Event or Problem · 1

    PT WAS REVISED TO A TOTAL KNEE ARTHROPLASTY ON (B)(6)-2011 DUE TO LINGERING PAIN. ACCORDING TO SURGEON, THE MAKO IMPLANTS WERE POSITIONED PROPERLY AND NO COMPONENTS WERE LOOSE. THE ORIGINAL MAKOPLASTY DATE WAS (B)(6)-2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORIS MCK UNICONDYLAR KNEE SYSTEM HSX MAKO SURGICAL 180513 26110510

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability