BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1

    MDR report key: 5197499 · Received November 3, 2015

    Report

    Report Number
    3005985723-2015-00232
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Date of Event
    September 17, 2015
    Report Date
    September 17, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K121064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING INACCURATE CUP VERSION INVOLVING RIO®UPGRADE DISK PKA 2.5.6.3 AND THA 3.1 (P/N 212042) WAS REPORTED. METHOD & RESULTS: -DEVICE HISTORY REVIEW:NOT PERFORMED AS THE REPORTED DEVICE IS SOFTWARE. -COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 211355) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING INACCURATE VERSION. THERE WERE 9 OTHER REPORTED EVENTS FOR THE LISTED CATALOG NUMBER. OF THOSE, NONE REPORTED INACCURATE VERSION. CONCLUSIONS: THE SESSION DATA AND POST-OP X-RAYS FROM THE CASE WERE REVIEWED. AN ANALYSIS OF THE LANDMARK/PELVIC REGISTRATION, POST-OP X-RAY, SYSTEM RESULTS, AND PATIENT ANATOMY WAS COMPLETED (SEE ATTACHMENT). BASED ON THE RESULTS OF POST-OP X-RAY ANALYSIS AND THE, THE ACTUAL CUP VERSION IS WITHIN 5 DEGREES OF THE ANGLE REPORTED BY THA 3.1 APPLICATION. THE OSTEOPHYTES ON THE POSTERIOR WALL OF THE ACETABULUM MAY CAUSE THE DIFFERENCE IN CUP VERSION DETERMINATION BETWEEN DR. JERABEK AND THA 3.1 APPLICATION. THE DATA AT THIS TIME SHOWS THAT THE THA 3.1 APPLICATION SYSTEM WORKED AS INTENDED DURING DR. (B)(6) CASE ON (B)(9) 2015. THE SURGEON CHANGED IMPLANT SYSTEM AFTER CUP IMPACTION. BY APPLICATION DESIGN, THE SOFTWARE CLEARED THE IMPACTED CUP CENTER IN REDUCTION RESULTS TO BE RE-CAPTURED BASED ON THE NEW IMPLANT SYSTEM SELECTION. REPORTED DEVICE IS SOFTWARE.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). AFTER STARTING TO IMPACT THE CUP, THE SURGEON FELT THE VERSION WAS OFF AND REPEATED REGISTRATION MULTIPLE TIMES TO CONFIRM IF A FALSE PASSING REGISTRATION OCCURRED. INTRAOPERATIVELY, SURGEON STATED THAT VERSION VALUES ON SOFTWARE SEEMED GREATER THAN ACTUAL VERSION. THE CASE WAS SUCCESSFUL AND THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). AFTER STARTING TO IMPACT THE CUP, THE SURGEON FELT THE VERSION WAS OFF AND REPEATED REGISTRATION MULTIPLE TIMES TO CONFIRM IF A FALSE PASSING REGISTRATION OCCURRED. INTRAOPERATIVELY, SURGEON STATED THAT VERSION VALUES ON SOFTWARE SEEMED GREATER THAN ACTUAL VERSION. THE CASE WAS SUCCESSFUL AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727401 RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1 STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. THA 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other