BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCK TIBIAL ONLAY INSERT- SZ 1- 9MM

    MDR report key: 4624371 · Received March 23, 2015

    Report

    Report Number
    3005985723-2015-00041
    Event Type
    Malfunction
    Date Received
    March 23, 2015
    Date of Event
    February 19, 2015
    Report Date
    February 19, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    DEVICE REVIEW OF THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED ON 31-DEC-2013. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE DEVICE IS DAMAGED ON THE INFERIOR SIDE DUE TO ATTEMPT AT IMPLANTATION. MACHINE MARKINGS ARE STILL PRESENT. THERE ARE NO SIGNS OF DELAMINATION OR DISCOLORATION. THE INVESTIGATION CONFIRMED THAT THE DEVICE WAS DAMAGED DURING ATTEMPT AT IMPLANTATION. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    A SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. DURING THE CASE WHILE THE SURGEON WAS MAKING THE TIBIAL INSERT TO THE BASEPLATE, THE TIBIAL INSERT WAS DAMAGED. THIS DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.

    Description of Event or Problem · 1

    A SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. DURING THE CASE WHILE THE SURGEON WAS MAKING THE TIBIAL INSERT TO THE BASEPLATE, THE TIBIAL INSERT WAS DAMAGED. THIS DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193626 MCK TIBIAL ONLAY INSERT- SZ 1- 9MM STEREOTAXIC DEVICE OLO MAKO SURGICAL CORP. 12041113-1

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other