BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 5192861 · Received October 30, 2015

    Report

    Report Number
    3005985723-2015-00227
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A LOCKING MECHANISM FAILURE WITH THE PARALLEL HIP END EFFECTOR WAS CONFIRMED. METHOD AND RESULTS: -DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS PERFORMED AND THE PARALLEL HIP END EFFECTOR EVENT WAS CONFIRMED. -DEVICE HISTORY REVIEW: BASED ON THE DEVICE HISTORY REVIEW THERE WERE NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION, THE CATSWEB AND TRACKWISE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING LOCKING MECHANISM FAILURE OF CATALOG: 206967, SERIAL NUMBER: 1900343, LOT #: 19070113, RMA #: 222235. THERE HAVE BEEN NO OTHER EVENTS FOR THE REFERENCED SERIAL NUMBER. THERE HAS BEEN ONE EVENT REFERENCED FOR THE LOT NUMBER, ISSUE 4675. CONCLUSIONS: THE PARALLEL HIP END EFFECTOR (P/N 206967, L/N 19070113) WAS EVALUATED VISUALLY AND FUNCTIONALLY UPON RECEIPT AND THE REPORTED EVENT WAS CONFIRMED.THE PARALLEL HIP END EFFECTOR SHOWED A FAILED LOCKING MECHANISM. SPECIFICALLY THE LOCKING MECHANISM SHOWS SIGNS OF OXIDATION, WHICH HAS MADE ACTUATING THE LOCKING MECHANISM DIFFICULT.

    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 WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). IT WAS NOTICED THAT THE SPRING MECHANISM MALFUNCTIONED AND THE KNOB IN THE BACK FALLS OUT..THIS DID NOT AFFECT THE CASE AND IT WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). IT WAS NOTICED THAT THE SPRING MECHANISM MALFUNCTIONED AND THE KNOB IN THE BACK FALLS OUT. THIS DID NOT AFFECT THE CASE AND IT WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721594 HIP END EFFECTOR, VARIABLE ANGLE STEREOTACTIC DEVICE, INSTRUMENT OLO MAKO SURGICAL CORP. SN 1900343

    Patients

    Seq Age Sex Outcome Treatment
    1 Other