BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTORIS MCK

    MDR report key: 2281245 · Received September 26, 2011

    Report

    Report Number
    3005985723-2011-00027
    Event Type
    Other
    Date Received
    September 26, 2011
    Date of Event
    August 27, 2011
    Report Date
    August 30, 2011
    Manufacturer
    MAKO SURGICAL
    Product Code
    HSX
    PMA / PMN Number
    K082172
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVISED IMPLANTS HAVE NOT BEEN RETURNED FOR INVESTIGATION. MAKO REQUESTED THE POST-OP X-RAYS FOR RECORD REVIEW. 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

    THIS PT HAD A POST-OPERATIVE INFECTION APPROX 3 MONTHS FROM HER MAKOPLASTY LATERAL ONLAY PROCEDURE (DOS (B)(6) 2011). THE HOSP STAFF MENTIONED THAT SHE HAD OTHER SURGERIES SINCE HER MAKO LATERAL ONLAY WAS PERFORMED. AS IS COMMON WITH INFECTED KNEES, THE SURGEON ELECTED TO PERFORM AN INCISION AND DRAINAGE (KNOWN AS AN I&D) WITH A POLY SWAP ON SATURDAY (B)(6) 2011. THE NEW, STERILE POLY (ALSO 2X8MM), WAS INSERTED AND THE I&D W POLY SWAP SURGERY CONCLUDED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORIS MCK UNICONDYLAR KNEE SYSTEM HSX MAKO SURGICAL 180702-1 12070209-1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention