MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Model Number 180702-1

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 02/28/2014

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 implants.The surgeon scheduled a revision procedure for suspected implant loosening.During the procedure, the surgeon discovered that the tibial and femoral implant components were properly affixed to the bone.The only tibial insert was exchanged for a thicker insert to tighten the joint.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been conducted by mako surgical.According to the surgeon, the reason for scheduling the revision procedure was suspected tibial loosening.During the inspection of the implants intraoperatively, there was no loosening of the tibial or femoral components.However, the knee joint was noted to be loose.The surgeon elected to replace the 8 mm thick onlay tibial insert component with a 10 mm thick insert to tighten the knee joint.

• 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; fort lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3736048
• MDR Text Key: 4306522
• Report Number: 3005985723-2014-00032
• 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: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180702-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 63 YR