MAUDE Adverse Event Report: MAKO RESTORIS; PROSTHESIS, KNEE

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 06/16/2016

Event Type  Injury  

Event Description

Bilateral partial knee replacement done (b)(6) 2016 using mako stryker restoris implants.Knee pain increased after surgery instead of correcting the pain.It continues to worsen for undetermined cause.

• Brand Name: RESTORIS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): MAKO
• MDR Report Key: 7052249
• MDR Text Key: 92863923
• Report Number: MW5073510
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Weight: 64