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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 ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 209999
Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Inadequate Osseointegration (2646)
Event Date 12/10/2020
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. Revised a right mako medial uni originally done on (b)(6) 2017 due to pain/tibial loosening. He revised to a primary triathlon. He noted the tibia was "easy to get out. " update 14/december/2020 wg: spoke to rep, patient was revised from a mako uni knee (with cemented femoral and tibial components) to a triathlon tka. Revision performed robotically. Rep confirmed there are no allegations against the revised femoral component or insert. Rep provided usage reports, x-rays, and explant pictures, and confirmed that no further information will be released by the hospital.
 
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Brand Name3.0 RIO ROBOTIC ARM - MICS
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
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
daniela davila
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key11114488
MDR Text Key225287132
Report Number3005985723-2021-00002
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
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 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
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 Received02/19/2021
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: 01/04/2021 Patient Sequence Number: 1
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