MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Model Number 180603

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Discomfort (2330)

Event Date 02/14/2014

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 tibial baseplate on the pt was suspected to be loose.The surgeon determined that the cementing technique was likely the cause, and planned a revision procedure.During the revision, the surgeon confirmed the tibial baseplate was loose, and had been placed too far posteriorly, which could have been the cause of the pt's discomfort.The rio was used to burr and create a new placement, and the tibial baseplate and onlay insert were replaced in a successful revision procedure.

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 cementing technique was likely the cause, which contributed to the loosening of the tibial baseplate.The component was also placed too far posteriorly, according to the surgeon.Improved implant placement and cementing technique were accomplished during the revision procedure.The session files from the rio system used in the original procedure were reviewed.All values in the system's session files were within acceptable tolerances, which indicates the rio operated as expected.

• 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., suite 110; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3698591
• MDR Text Key: 4228395
• Report Number: 3005985723-2014-00027
• Device Sequence Number: 1
• Product Code: HSX
• 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: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180603
• Device Lot Number: 26170613-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2014
• 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 SYSTEM (RIO)
• Patient Outcome(s): Required Intervention