MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 05/17/2019

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.Device not returned.

Event Description

This pi is for the robot used in the primary procedure patient had a right mako tha surgery on (b)(6) 2019.She started to experience drainage from incision approx.(b)(6) 2019.The incision opened on (b)(6) 2019, patient went to the er and was admitted.Patient was partially revised on (b)(6) 2019.Patient was discharged a week after revision and was given antibiotics.On (b)(6) 2019 patient went for a follow-up visit and was told to follow up with her original surgeon.Patient went to see the original surgeon the same day and was admitted to the hospital.During her hospital stay, multiple i&ds were performed approx.(b)(6) 2019.Patient was discharged on (b)(6) 2019.Patient continued to experience drainage after being discharged.All components were revised on (b)(6) 2019 and a cement spacer was placed.Another i&d was performed on (b)(6) 2019 and was placed in rehab.On (b)(6) 2019 the spacer was removed, and patient was implanted with competitor product.

Manufacturer Narrative

Update d2.Reported event: it was reported that ¿patient had a right mako tha surgery on (b)(6) 2019.She started to experience drainage from incision approx.(b)(6) 2019.The incision opened on (b)(6) 2019, patient went to the er and was admitted.Patient was partially revised on (b)(6) 2019.Patient was discharged a week after revision and was given antibiotics.On (b)(6) 2019 patient went for a follow-up visit and was told to follow up with her original surgeon.Patient went to see the original surgeon the same day and was admitted to the hospital.During her hospital stay, multiple i&ds were performed approx.(b)(6) 2019, (b)(6) 2019 and on (b)(6) 2019.Patient was discharged on (b)(6) 2019.Patient continued to experience drainage after being discharged.All components were revised on (b)(6) 2019 and a cement spacer was placed.Another i&d was performed on (b)(6) 2019 and was placed in rehab.On (b)(6) 2019 the spacer was removed, and patient was implanted with competitor product.¿.Product evaluation and results: review of the case session files was not performed as case session data was not provided.Product history 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 tha software - other.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information such as 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.

Event Description

This pi is for the robot used in the primary procedure patient had a right mako tha surgery on (b)(6) 2019.She started to experience drainage from incision approx.(b)(6) 2019.The incision opened on (b)(6) 2019, patient went to the er and was admitted.Patient was partially revised on (b)(6) 2019.Patient was discharged a week after revision and was given antibiotics.On (b)(6) 2019 patient went for a follow-up visit and was told to follow up with her original surgeon.Patient went to see the original surgeon the same day and was admitted to the hospital.During her hospital stay, multiple i&ds were performed approx.(b)(6) 2019, (b)(6) 2019 and on (b)(6) 2019.Patient was discharged on (b)(6) 2019.Patient continued to experience drainage after being discharged.All components were revised on (b)(6) 2019 and a cement spacer was placed.Another i&d was performed on (b)(6) 2019 and was placed in rehab.On (b)(6) 2019 the spacer was removed, and patient was implanted with competitor product.

• 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 Key: 9607703
• MDR Text Key: 180582522
• Report Number: 3005985723-2020-00051
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 113