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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209999
Device Problems Computer Software Problem (1112); Non Reproducible Results (4029)
Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2019
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
This pi is for the robot used in primary surgery.It was reported that the patient's left hip was revised due to a femoral periprosthetic fracture sustained in a fall.A secur-fit advanced stem, 36 +0 biolox ceramic head, and 36e poly liner were revised to an adm/mdm liner construct with competitor stem and head.Rep reported that no further information would be released by the hospital or surgeon.
 
Manufacturer Narrative
Follow-up #1 and final report submitted to update sections based on the results of investigation.Reported event: an event regarding revision involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: not performed as the device being inspected is software.Rio serial number not reported.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding revision.There were 7 other reported event for the listed catalog number (pr1442085, pr1737869, pr1898251, pr1930169, pr1950907, pr1962866, and pr2008297).Conclusion: product inspection could not be completed due to no logs or session files not being available from hospital or surgeon.Evaluation could not be performed because the logs/session files were not provided.
 
Event Description
This pi is for the robot used in primary surgery.It was reported that the patient's left hip was revised due to a femoral periprosthetic fracture sustained in a fall.A secur-fit advanced stem, 36 +0 biolox ceramic head, and 36e poly liner were revised to an adm/mdm liner construct with competitor stem and head.Rep reported that no further information would be released by the hospital or surgeon.
 
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Brand Name
3.0 RIO® ROBOTIC ARM - MICS
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key8416317
MDR Text Key138659815
Report Number3005985723-2019-00224
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number209999
Was Device Available for Evaluation? No
Date Manufacturer Received04/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age66 YR
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