BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J6 ARM FOR HIP WITH QD

    MDR report key: 5370747 · Received January 15, 2016

    Report

    Report Number
    3005985723-2016-00018
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    December 28, 2015
    Report Date
    December 28, 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

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: THE REPORTED DEVICE WAS CONFIRMED TO BE A J6 ARM FOR HIP WITH QD, P/N 203477, LOT ROB338. DEVICE EVALUATION AND RESULTS: ACCORDING TO GSP CASE (B)(4), THE FIELD SERVICE ENGINEER CONFIRMED THE FAILURE, FINDING THAT THE J6 ENCODER HAD COME LOOSE FROM ITS MOUNT. DEVICE HISTORY REVIEW: REVIEW OF THE DHR INDICATES THAT (B)(4), WHICH INCLUDED THE ALLEGEDLY FAILING COMPONENT, WAS COMPLETED AND ACCEPTED INTO STOCK ON (B)(6) 2015. THERE WAS ONE NONCONFORMANCE ((B)(4)), WHICH WAS RESOLVED PRIOR TO PRODUCT RELEASE. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 203477 SHOWS 1 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION (PI 1034876). TRACKING OF COMPLAINTS RELATED TO THE 203477 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #813. CONCLUSIONS: THE FAILURE WAS CONFIRMED BY THE FSE. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    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). DURING IMPACTION THE CUP WAS 1MM PROUD, THE SURGEON TRIED TO GET THE CUP TO 0MM PROUD BUT A "WARNING JOINT ANGLES INCONSISTENT" APPEARED AND THE CASE WAS CONVERTED TO MANUAL. 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). DURING IMPACTION THE CUP WAS 1MM PROUD, THE SURGEON TRIED TO GET THE CUP TO 0MM PROUD BUT A "WARNING JOINT ANGLES INCONSISTENT" APPEARED AND THE CASE WAS CONVERTED TO MANUAL. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30116 J6 ARM FOR HIP WITH QD STEREOTACTIC DEVICE, ROBOTIC OLO MAKO SURGICAL CORP. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other