MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Model Number 180513

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/22/2014

Event Type  Injury  

Event Description

The surgeon performed a revision on a pt who had received a right partial knee arthroplasty using the robotic arm interactive orthopedic system (rio) four months prior.The femoral component and tibial insert were both replaced; the tibial baseplate was not revised.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation has been initiated with regard to this event.The implants were not returned for review.Case session files were reviewed and all accuracy values were found to be within acceptable tolerances.The implant plan for the femur included a value for flexion set at 6 degrees.The recommended range for flexion is 5 degrees or less.The surgeon stated that it was a cementing technique issue on his part that caused the femoral loosening.

• Brand Name: RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
• Type of Device: COMPARTMENTAL KNEE PROSTHESIS
• Manufacturer (Section D): MAKO SURGICAL; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie road; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3670345
• MDR Text Key: 4344528
• Report Number: 3005985723-2014-00011
• 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: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 180513
• Device Lot Number: 26150712-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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 SYSTEM (RIO)
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR