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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
Model Number 209999
Device Problems Loss of Osseointegration (2408); Output Problem (3005)
Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Event Date 08/06/2019
Event Type  Injury  
Manufacturer Narrative
As part of the 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
Pi for the robot, rob 276, that was used in the primary surgery for the patient in (b)(4). Revision of a restoris medial unicompartment knee to a total knee replacement with mr (b)(6) at (b)(6) hospital. Patient had a revision undertaken due to pain upon walking. Femoral component appeared well fixed, tibial component was easily moved during the revision. Once implants were removed the tibial implant showed no visible signs of bonding to the cement nor the bone. Femur was well fixed. A total knee replacement was completed satisfactorily using a triathlon ps implant, without delay.
 
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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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9100866
MDR Text Key159516989
Report Number3005985723-2019-00685
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAU
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 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number209999
Device Catalogue Number209999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2020
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: 09/20/2019 Patient Sequence Number: 1
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