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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.".
 
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.".
 
Manufacturer Narrative
Reported event: an event regarding paininvolving an unknown robot during a mako tka was reported.The eventwas not confirmed.It was reported ¿a patient sent the following email: "hello, i don¿t have a complaint, although i do have a question.I had a total knee replacement december 30, 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 kneecap? i was told my kneecap 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/kneecap 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 provide some information.¿ product evaluation and results: review of the case session files was not performed as case session data was not provided.Clinician review:no medical records were received for review with a clinical consultant.Product history review: review of the device history records was not completed as the robot number/product information was not provided.Complaint history review: a search of the complaint database under device identification pn 209999 reports no similar complaints for tka software - other.Conclusions: it was reported that patient had pain and discomfort.The exact cause of the event could not be determined because no case session data or logs were provided after three communication attempts were made.If additional information is received then the complaint will be reopened.
 
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Brand Name
3.0 RIO ROBOTIC ARM - MICS
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key9953762
MDR Text Key188357506
Report Number3005985723-2020-00194
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number209999
Device Catalogue Number209999
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/19/2020
Initial Date FDA Received04/13/2020
Supplement Dates Manufacturer Received07/23/2020
Supplement Dates FDA Received08/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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