BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1

    MDR report key: 5240345 · Received November 20, 2015

    Report

    Report Number
    3005985723-2015-00270
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    August 26, 2015
    Report Date
    October 1, 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 CUP VERSION/INCINATION INVOLVING RIO®UPGRADE DISK PKA 2.5.6.3 AND THA 3.1 (P/N 211355) WAS REPORTED. METHOD AND RESULTS: DEVICE HISTORY REVIEW:NOT PERFORMED AS THE REPORTED DEVICE IS SOFTWARE. RIO SERIAL NUMBER NOT REPORTED. 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 (B)(4) OTHER REPORTED EVENTS FOR THE LISTED CATALOG NUMBER. OF THOSE, ONLY (B)(4) WERE RELATED TO INACCURATE VERSION/INCLINATION ((B)(4)). 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 THE SESSION DATA AND POST-OP X-RAYS FROM THE CASE WERE REVIEWED. AN ANALYSIS OF THE LANDMARK/PELVIC REGISTRATION, POST-OP X-RAY, AND SYSTEM RESULTS WAS COMPLETED. BASED ON THE RESULTS OF POST-OP X-RAY ANALYSIS, THE ACTUAL CUP INCLINATION IS WITHIN 5 DEGREES OF THE ANGLE REPORTED BY THA 3.1 APPLICATION. THE THA 3.1 APPLICATION SYSTEM WORKED PROPERLY IN DR. (B)(6) CASE ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    .

    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 STATED THAT THE ROBOTIC INCLINATION VERSION VALUES SEEMED TO DIFFER FROM THE ACTUAL INCLINATION AND VERSION VALUES. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    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 STATED THAT THE ROBOTIC INCLINATION VERSION VALUES SEEMED TO DIFFER FROM THE ACTUAL INCLINATION AND VERSION VALUES. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    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 STATED THAT THE ROBOTIC INCLINATION VERSION VALUES SEEMED TO DIFFER FROM THE ACTUAL INCLINATION AND VERSION VALUES. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770808 RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1 STEREOTACTIC DEVICE OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other