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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 Problem Insufficient Information (3190)
Patient Problems Scar Tissue (2060); Discomfort (2330); Injury (2348)
Event Date 12/30/2019
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. Device not returned.
 
Event Description
A patient sent the following email: "i don¿t have a complaint, although i do have a question. I had a total knee replacement (b)(6) 2019, my doctor performed my surgery using the mako robotic assist. When you have a ct scan does it show you the details of the knee cap? i was told my knee cap had slipped which my doctor and i were completely unaware. Also, my doctor indicated my femur bone was like mush. The ct scan allows for the removal of the damaged bone, in my case would the doctor have to make an adjustment if he felt the bone was in worse shape? unfortunately, i was told about these issues but never an answer on how they corrected them. Another words should my patella/knee cap needed to be replaced with a new one? was more of my femur bone removed? i¿m 10 weeks post op and have this tightening along my femur bone. I¿m still experiencing a lot of discomfort at night. My knee is completely stiff while lying on my right side after an hour and i have to roll on to my back and stretch my leg several times, or get up and stretch it, this goes on all night. I know according to my doctor i have developed scar tissue which i¿m working with a physical therapist to break up. My bend, or range of motion is currently at 117 degrees. The other question i have is why my doctor placed a press fit at the tibia and cement on the femur side. Hopefully you can some provide information, thank you. ".
 
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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 Key9953762
MDR Text Key188357506
Report Number3005985723-2020-00194
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number209999
Device Catalogue Number209999
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
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: 04/13/2020 Patient Sequence Number: 1
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