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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 Problem Insufficient Information (3190)
Patient Problems Injury (2348); No Information (3190)
Event Date 11/18/2019
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
This pi is for the robot used in the primary.It was reported that the patient's left mako uni knee was revised.Pre-op diagnosis is failed unicompartmental knee replacement.Surgeon reported the development of patellofemoral disease.The patient's mako uni knee was revised to a ts total knee.Primary procedure was done at an unknown hospital by an unknown surgeon.Rep reported that no further information will be available.
 
Event Description
This pi is for the robot used in the primary.It was reported that the patient's left mako uni knee was revised.Pre-op diagnosis is failed unicompartmental knee replacement.Surgeon reported the development of patellofemoral disease.The patient's mako uni knee was revised to a ts total knee.Primary procedure was done at an unknown hospital by an unknown surgeon.Rep reported that no further information will be available.
 
Manufacturer Narrative
Reported event: an event regarding revision due to patient factors (development of patellofemoral disease) involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported that ¿it was reported that the patient's left mako uni knee was revised.Pre-op diagnosis is failed unicompartmental knee replacement.Surgeon reported the development of patellofemoral disease.The patient's mako uni knee was revised to a ts total knee.Primary procedure was done at an unknown hospital by an unknown surgeon.Rep reported that no further information will be released by the hospital or surgeon." product evaluation and results: not performed as case session data was not provided.Product history review review of the device history records was not completed as the robot number was not provided.Complaint history review a search of the complaint database under device identification pn 209999 reports no similar complaints for pka software - other.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays, return of the device and case session data/logs are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Corrective action/preventive action: a search of the nc/capa database under device identification pn 209999 reports no records related to pka software - other.H3 other text : device not returned.
 
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Brand Name
3.0 RIO® ROBOTIC ARM - MICS
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key9476145
MDR Text Key175447402
Report Number3005985723-2019-00907
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 health professional
Type of Report Initial,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
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
Date Manufacturer Received03/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age81 YR
Patient Weight76
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