MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209999

Device Problem Insufficient Information (3190)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2017

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.(b)(6) revised a right knee that had medial, lateral and pf uni knees to a total knee triathlon.He kept the original patella component in place.Update 10/04/2017: patient had a primary procedure for the medial aspect on (b)(6) 2015.Patient had another procedure for the lateral and pf aspects on (b)(6) 2016 (no stryker devices were explanted at that time).All components except the patella component were explanted on (b)(6) 2017.

Manufacturer Narrative

Reported event: the reported device is a 3.0 rio® robotic arm - mics, catalog: 209999.Device history review: a review of the dhr associated with rio 118 found quality inspection procedures and pt review successfully passed.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding a revision from a partial knee procedure to a total knee procedure.There were other reported events ((b)(6)).Conclusion: no investigation was conducted since no information was provided.The device was not returned for evaluation.

Event Description

Dr.(b)(6) revised a right knee that had medial, lateral and pf uni knees to a total knee triathlon.He kept the original patella component in place.Update 10/04/2017: patient had a primary procedure for the medial aspect on (b)(6) 2015.Patient had another procedure for the lateral and pf aspects on (b)(6) 2016 (no stryker devices were explanted at that time).All components except the patella component were explanted on (b)(6) 2017.

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6928140
• MDR Text Key: 89154586
• Report Number: 3005985723-2017-00486
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR