MAUDE Adverse Event Report: MAKO SURGICAL CORP. RESTORIS MULTICOMPARTMENT KNEE PROSTHESIS; COMPARTMENTAL KNEE PROTHESIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rheumatoid Arthritis (1724)

Event Date 07/16/2014

Event Type  Injury  

Event Description

The patient had received a left partial knee arthroplasty procedure, performed using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.The patient recovered well enough to have the procedure performed on their right knee less than nine months later.However, the patient developed pan and swelling in the left knee, and the surgeon elected to perform a total knee replacement.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated at mako surgical.The patient was diagnosed with rheumatoid arthritis, and was experiencing synovitis.The pain and inflammation experienced by the patient is believed to have been caused by the rheumatoid arthritis, and not by any deficiency with the implants or implant placement.Further evaluation is ongoing, and a supplemental report will be filed if additional information is obtained.

• Brand Name: RESTORIS MULTICOMPARTMENT KNEE PROSTHESIS
• Type of Device: COMPARTMENTAL KNEE PROTHESIS
• Manufacturer (Section D): MAKO SURGICAL CORP.; ft. lauderdale FL 33317
• Manufacturer Contact: william tapia ; 2555 davie rd., suite 110; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 4017567
• MDR Text Key: 4846600
• Report Number: 3005985723-2014-00103
• Device Sequence Number: 1
• Product Code: HRY
• 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: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2014
• 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): Required Intervention