MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Model Number 180602

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

The surgeon was performing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.Prior to implanting the tibial baseplate, the surgeon noticed there was residue on the top surface of the implant.The implant was not used and a new implant was used.This event did not affect the outcome of the case which was successful.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event was completed at mako surgical.A supplemental report will be filed when additional information is obtained.

• Brand Name: RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
• Type of Device: COMPARTMENTAL KNEE PROSTHESIS
• Manufacturer (Section D): MAKO SURGICAL; fort lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd.; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 4268013
• MDR Text Key: 5225237
• Report Number: 3005985723-2014-00189
• Device Sequence Number: 1
• Product Code: KRR
• 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: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 180602
• Device Lot Number: 26130214-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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)