BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 4209180 · Received September 12, 2014

    Report

    Report Number
    3005985723-2014-00131
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    HRY
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT WAS COMPLETED AT MAKO SURGICAL. A NON-CONFORMING REPORT (NPR) WAS CREATED. THE PACKAGING CONFIGURATION OF THE PRODUCT REFERENCED IN (B)(4) CONSISTS OF TWO REDUNDANT STERILE BARRIERS ((B)(4)), ENCASED BY A RIGID PLASTIC BOX. ALL PRODUCT RETURNED WAS VISUALLY INSPECTED BY A TEAM OF ENGINEERS. THE INSPECTION CONSISTED OF VISUALLY INSPECTING EACH LAYER OF PACKING FOR DISCOLORATION. THE ENGINEER LEADING THE INSPECTION NOTED THAT NONE OF THE PRODUCT RETURNED HAD DISCOLORATION PAST THE OUTER RIDGED PLASTIC BOX. MAKO HAS ALSO FOLLOWED UP WITH THE SURGEON WHO IMPLANTED THE DEVICE FROM THE SAME KIT OF (B)(4) DEVICES. THE SURGEON REPORTED THAT THE PATIENT HAD NO INFECTION OR POST-OPERATIVE COMPLICATIONS. THE (B)(4) RETURNED UNITS HAVE BEEN SCRAPPED.

    Description of Event or Problem · 1

    UPON RECEIPT AT THE HOSPITAL, THE MAKO REPRESENTATIVE NOTED THAT THE PN 180408 (PATELLOFEMORAL COMPONENT, SIZE 8) IMPLANT FROM THE PN 150135 (SERIAL # (B)(4)) IMPLANT SHIPPING CONTAINER APPEARED TO HAVE AN UNIDENTIFIED STAIN PRESENT UNDER THE SHRINK WRAP ON THE BOX LABEL. THIS IMPLANT WAS SEPARATED AND PLACED IN A (B)(4) BAG FOR RETURN. TWO IMPLANTS FROM THE KIT, WHICH EXHIBITED NO VISIBLE DAMAGE, WERE USED IN THE CASE. THE REMAINING IMPLANTS WERE RETURNED ((B)(4)) TO MAKO FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566713 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS HRY MAKO SURGICAL 180418 14011009-6

    Patients

    Seq Age Sex Outcome Treatment
    1 ROBOTIC ARM INTERACTIVE SYSTEM (RIO)