MAUDE Adverse Event Report: MAKO SURGICAL CORP. RESTORIS MULTICOMPARTMETNAL KNEE PROSTHESIS

Model Number 180708-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 04/17/2014

Event Type  Injury  

Event Description

A pt had received a partial knee arthroplasty, which was performed using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants on (b)(6) 2014.Approximately two weeks later, the surgeon replaced the onlay tibial insert component with a component of the same size.

Manufacturer Narrative

No info regarding the reason for the exchange of the onlay tibial insert component is know at this time.An evaluation of this event is currently underway at mako surgical.A supplemental report will be filed if additional info is obtained.

• Brand Name: RESTORIS MULTICOMPARTMETNAL KNEE PROSTHESIS
• Type of Device: COMPARTMETNAL KNEE PROSTHESIS
• Manufacturer (Section D): MAKO SURGICAL CORP.; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3877765
• MDR Text Key: 16083230
• Report Number: 3005985723-2014-00066
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: 180708-1
• Device Lot Number: 12040211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS (RIO)
• Patient Outcome(s): Required Intervention