MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTEMTNAL KNEE PROSTHESIS; COMPARTMENTAL KNEE PROSTHESIS

Model Number 180704-1

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 02/27/2014

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 onlay tibial insert was replaced with a component of the same size.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been conducted by mako surgical.According to the surgeon, there was no loosening of the tibial or femoral components.Removing the onlay tibial insert was required to facilitate inspection of the femoral and tibial components, and the removal process damages the insert.Therefore, the surgeon replaced the onlay tibial insert with a new component of the same size and model number.No further adverse events have been reported for this pt; the reason for the originally reported discomfort is inconclusive.

• Brand Name: RESTORIS MULTICOMPARTEMTNAL 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: 3736047
• MDR Text Key: 4276804
• Report Number: 3005985723-2014-00033
• 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: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180704-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• 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