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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 12/29/2018
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 the primary procedure.It was reported through the submission of a revision implant sheet that the patient's left hip was revised.A restoration modular stem construct, 32 +8 lfit v40 head, and 3 dall-miles cable and sleeve sets were implanted.Spoke to rep.Patient fell and sustained a femoral periprosthetic fracture.An anato stem and stryker head were revised.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.
 
Manufacturer Narrative
Reported event: an event regarding revision due to loosened implant involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 163 found quality inspection procedures successfully passed.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 6 other reported event for the listed catalog number (pr1442085, pr1737869, pr1898251, pr1930169, pr1950907, and pr1962866).Conclusion: product inspection could not be completed due to no logs or session files not being available due to hospital policy.
 
Event Description
This pi is for the robot used in the primary procedure.It was reported through the submission of a revision implant sheet that the patient's left hip was revised.A restoration modular stem construct, 32 +8 lfit v40 head, and 3 dall-miles cable and sleeve sets were implanted.Spoke to rep.Patient fell and sustained a femoral periprosthetic fracture.An anato stem and stryker head were revised.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.
 
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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 Key8239731
MDR Text Key132794412
Report Number3005985723-2019-00044
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 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2019
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 Received03/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age69 YR
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