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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 Problem Insufficient Information (3190)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 02/06/2017
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
Dr (b)(6) revised a mako unicondylar knee originally implanted on (b)(6) 2016 by dr (b)(6). Dr (b)(6) explanted the uni and converted to a tka. The tibial implant was found to be loose and acl was found to be compromised.
 
Manufacturer Narrative
Reported event: an event regarding over implant loosening involving 3. 0 rio robotic arm - mics, catalog: 209999 was reported. Method and 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 the complaint databases were reviewed from 2011 to present for similar reported events regarding implant loosening. There were 6 other reported events (b)(4). Conclusion: device inspection could not be performed, no session data was provided. Three communication attempts were made. The device was not returned for evaluation.
 
Event Description
Dr (b)(6) revised a mako unicondylar knee originally implanted on (b)(6) 2016 by dr (b)(6). Dr (b)(6) explanted the uni and converted to a tka. The tibial implant was found to be loose and acl was found to be compromised.
 
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Brand Name3.0 RIO® ROBOTIC ARM - MICS
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
michael mcavenia
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key6349779
MDR Text Key68033927
Report Number3005985723-2017-00088
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number209999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/22/2017 Patient Sequence Number: 1
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