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 Hematoma (1884); Injury (2348)

Event Date 03/29/2019

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

During a mako clinical trial adverse event data report it was found that a patient had a hematoma.

Manufacturer Narrative

Update to d2.Reported event: it was reported ¿ during a mako clinical trial adverse event data report it was found that a patient had a hematoma.Update 31/march/2020 wg: as reported in adverse consequences details: surgery for evacuation of a hematoma¿ product evaluation and results: review of the case session files was 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 tka software - other.Additionally there were no device specific failure modes were identified.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.H3 other text : device not returned.

Event Description

During a mako clinical trial adverse event data report it was found that a patient had a hematoma.Update 31/march/2020 wg: as reported in adverse consequences details: surgery for evacuation of a hematoma.

• 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: 9780157
• MDR Text Key: 181781687
• Report Number: 3005985723-2020-00126
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• 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: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention