MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT STEREOTAXIC DEVICE, ROBOTICS

Catalog Number UNK_OFL

Device Problem Insufficient Information (3190)

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

Event Date 05/18/2016

Event Type  Injury  

Manufacturer Narrative

Follow-up #1 and final report submitted to update. Based on the results of investigation. Reported event: the reported device is a 3. 0 rio® robotic arm - mics, catalog: 209999. Method & results: device history review: a review of the dhr associated with rio 119 found quality inspection procedures and pt review successfully passed. Complaint history: based on the device identification (pn (b)(4)) 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)(4)). Conclusion: no investigation was conducted since no information was provided. The device was not returned for evaluation.

Event Description

This pi was raised in relation to (b)(4). Event description; dr. (b)(6) revised a total knee due to instability. He changed the tibial insert from a size 16 to a 19 cs. The patient originally had a mako uni knee done in 2011, then was revised to a total knee on (b)(6) 2016. This pi is for the revision surgery which took place on (b)(6) 2016.

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

This pi was raised in relation to (b)(4). Event description; dr. (b)(6) revised a total knee due to instability. He changed the tibial insert from a size 16 to a 19 cs. The patient originally had a mako uni knee done in 2011, then was revised to a total knee on (b)(6) 2016. This pi is for the revision surgery which took place on (b)(6) 2016.

• Brand Name: UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT
• 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: liza gordillo ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6650055
• MDR Text Key: 117738635
• Report Number: 3005985723-2017-00255
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK_OFL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/18/2017
• 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 Treatment Data

Date Received: 06/19/2017 Patient Sequence Number: 1