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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number UNK_OFL
Device Problem Insufficient Information (3190)
Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2016
Event Type  Injury  
Manufacturer Narrative
Follow-up #1 and final report submitted to update. Based on the results of investigation. Reported event: the reported device is a 3. 0 rio® robotic arm - mics, catalog: 209999. Method & results: device history review: a review of the dhr associated with rio 119 found quality inspection procedures and pt review successfully passed. Complaint history: based on the device identification (pn (b)(4)) the complaint databases were reviewed from 2011 to present for similar reported events regarding a revision from a partial knee procedure to a total knee procedure. There were other reported events ((b)(4)). Conclusion: no investigation was conducted since no information was provided. The device was not returned for evaluation.
 
Event Description
This pi was raised in relation to (b)(4). Event description; dr. (b)(6) revised a total knee due to instability. He changed the tibial insert from a size 16 to a 19 cs. The patient originally had a mako uni knee done in 2011, then was revised to a total knee on (b)(6) 2016. This pi is for the revision surgery which took place on (b)(6) 2016.
 
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 was raised in relation to (b)(4). Event description; dr. (b)(6) revised a total knee due to instability. He changed the tibial insert from a size 16 to a 19 cs. The patient originally had a mako uni knee done in 2011, then was revised to a total knee on (b)(6) 2016. This pi is for the revision surgery which took place on (b)(6) 2016.
 
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Brand NameUNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT
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
liza gordillo
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key6650055
MDR Text Key117738635
Report Number3005985723-2017-00255
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 07/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_OFL
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 Received07/18/2017
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: 06/19/2017 Patient Sequence Number: 1
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