MAUDE Adverse Event Report: MAKO SURGICAL CORP. RESTORIS MULTICOMPARMENTAL KNEE PROSTHESIS

Model Number 180505

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 03/24/2014

Event Type  Injury  

Event Description

A surgeon informed mako surgical that he revised a patient on (b)(6), 2014 who had previously underwent a partial knee arthroplasty case using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee implants on (b)(6), 2012.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been complained of increased pain in the left knee.The radiograph of the femoral component showed lucency.The surgeon stated that the femoral component was loose and was due to cementing technique.The surgeon removed the femoral component and replaced it with a competitive femoral implant.The tibial baseplate component was deemed sufficient and was left in place.The 8 mm thick onlay tibial insert was removed and replaced with a 10 mm mako esyntial onlay tibial insert.

• Brand Name: RESTORIS MULTICOMPARMENTAL KNEE PROSTHESIS
• Type of Device: COMPARMENTAL KNEE PROSTHESIS
• Manufacturer (Section D): MAKO SURGICAL CORP.; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd.; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3767546
• MDR Text Key: 4480959
• Report Number: 3005985723-2014-00040
• 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: 03/24/2014

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: 08/31/2016
• Device Model Number: 180505
• Device Lot Number: 26360711-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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: TIBIAL INSERT: (B)(4) EXP.08/31/2016; ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR