MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Model Number 180612

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Injury (2348)

Event Date 01/08/2014

Event Type  Injury  

Event Description

A makoplasty partial knee arthroplasty patient fell and suffered an injury, which reportedly loosened the implant.The surgeon took x-rays, detected loosening, and performed a revision procedure.During the procedure, the surgeon removed the tibial baseplate and onlay insert components and implanted new components.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation has been conducted with regard to this event.The surgeon stated that he detected loosening from the patient x-rays.No prior issues were reported for this patient in over six months following the original surgery.Based on the information available at this time, the most likely root cause of implant loosening is the patient's fall.

• 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 rd.; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3625141
• MDR Text Key: 21449362
• Report Number: 3005985723-2014-00007
• 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: 01/08/2014

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: 02/28/2018
• Device Model Number: 180612
• Device Lot Number: LET1472581012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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: 46 YR