BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM -RIO

    MDR report key: 2820548 · Received October 24, 2012

    Report

    Report Number
    3005985723-2012-00218
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K081867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONVERSATION WITH THE SURGEON REVEALED THE FOLLOWING INFORMATION: THE PATIENT WAS PLAYING GOLF POST-OPERATIVELY (IT IS UNKNOWN HOW LONG POST-OPERATIVELY THIS INCIDENT OCCURRED) WHEN HE HEARD A "CRUNCH" IN HIS KNEE FOLLOWED BY IMMEDIATE PAIN. THE PATIENT WENT IN TO SEE THE SURGEON FOLLOWING THE INCIDENT. UPON X-RAY, THE SURGEON NOTICED A "CLUMP OF CEMENT" HAD DETACHED FROM THE POSTERIOR BASEPLATE AND FLOATING LOOSELY IN THE JOINT, LIKELY BEING THE CAUSE OF THE PATIENT'S PAIN. THE SURGEON STATED THAT HE MUST HAVE NOT NOTICED THE EXCESS CEMENT UPON CLOSING THE WOUND DURING THE INITIAL PROCEDURE. UPON RETROACTIVE REVIEW, THE POSTERIOR CLUMP OF CEMENT WAS VISIBLE ON THE PATIENT'S IMMEDIATE POST-OPERATIVE X-RAY AS WELL. THE SURGEON PERFORMED AN ARTHROSCOPIC PROCEDURE ON THE PATIENT TO SUCCESSFULLY REMOVE THE EXCESS CEMENT. THE PATIENT HAS MADE A FULL RECOVERY AND IS NOT EXPERIENCING ANY MORE PAIN.

    Description of Event or Problem · 1

    THE WIFE OF A MAKOPLASTY PARTIAL KNEE ARTHROPLASTY PATIENT INFORMED MAKO THAT THE PATIENT HAD UNDERGONE AN ARTHROSCOPIC REVISION SURGERY ON (B)(6) 2012, TO REMOVE A PIECE OF CEMENT THAT HAD COME LOOSE AND WAS CAUSING JOINT PAIN. THE ORIGINAL MAKOPLASTY SURGEON PERFORMED THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM -RIO STEREOTAXIC INSTRUMENT HAW MAKO SURGICAL 201000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS