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

Model Number 180707-1

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

Patient Problem Unspecified Infection (1930)

Event Date 05/27/2014

Event Type  Injury  

Event Description

The surgeon (b)(6) performed a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.Approx one week after the surgery, the pt was treated for a suspected post-operative infection that caused a pre-patellar hematoma in the pt's right knee.Immediately upon making the incision during the revision procedure, a greenish pus secreted from the wound and confirmed infection.The tibial onlay insert was exchanged, as is commonly practiced in this situation, as well as removal of the hematoma and infected tissue.The implants were not suspected as being the cause of the infection, but instead was hospital acquired.

Manufacturer Narrative

As part of normal complaint follow up, an eval of the event has been initiated at mako surgical.An onlay tibial insert exchange is routine procedure for wounds that appear inflamed or are infected after surgery.At this time, no mako implant component has been known to have contributed to post-operative inflammation or infection.

• Brand Name: RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
• Type of Device: COMPARTMENTAL KNEE PROTHESIS
• Manufacturer (Section D): MAKO SURGICAL; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd.; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3901503
• MDR Text Key: 4544658
• Report Number: 3005985723-2014-00080
• 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: Other
• Type of Report: Initial
• Report Date: 05/27/2014

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: 04/30/2018
• Device Model Number: 180707-1
• Device Lot Number: 12040213-2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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: 57 YR