BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1

    MDR report key: 5246031 · Received November 24, 2015

    Report

    Report Number
    3005985723-2015-00276
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Date of Event
    October 28, 2015
    Report Date
    October 28, 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

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING INACCURATE, INVOLVING A RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1, CATALOG: 211355 WAS REPORTED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: DEVICE INSPECTION COULD NOT BE PERFORMED, NO SESSION DATA WAS PROVIDED. FOUR COMMUNICATIONS WERE MADE TO MPS. -DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW WAS NOT COMPLETED AS THE REPORTED DEVICE IS SOFTWARE. NO SYSTEM SERIAL NUMBER WAS PROVIDED. -COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 211355) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING INACCURATE INCLINATION. THERE WERE NO OTHER REPORTED EVENTS FOR THE LISTED CATALOG NUMBER. SOFTWARE DEVICE.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). THE SURGEON DISAGREED WITH THE INCLINATION VALUE READOUT ON SOFTWARE AND STATED THAT THE CUP APPEARED MORE HORIZONTAL ON POST-OP X-RAY. THE OUTCOME OF THE CASE WAS SUCCESSFUL AND THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). THE SURGEON DISAGREED WITH THE INCLINATION VALUE READOUT ON SOFTWARE AND STATED THAT THE CUP APPEARED MORE HORIZONTAL ON POST-OP X-RAY. THE OUTCOME OF THE CASE WAS SUCCESSFUL AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778191 RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1 STEREOTACTIC DEVICE OLO MAKO SURGICAL CORP. 69

    Patients

    Seq Age Sex Outcome Treatment
    1 Other