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

Model Number 180505

Device Problem Osseointegration Problem (3003)

Patient Problem Arthralgia (2355)

Event Date 06/25/2014

Event Type  Injury  

Event Description

The surgeon had performed bilateral partial knee arthroplasty procedures using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants in (b)(6) 2012.The patient recently started to complain about pain, so the surgeon decided to perform a revision to a total knee replacement.The surgeon discovered that the femoral component was loose, and the tibial baseplate was well fixed.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated at mako surgical.The investigation is ongoing, and a supplemental report will be filed if further information is obtained.

• Brand Name: RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
• Type of Device: COMPARTMENTAL KNEE PROTHESIS
• Manufacturer (Section D): MAKO SURGICAL CORP.; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd., suite 110; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 4017852
• MDR Text Key: 4711199
• Report Number: 3005985723-2014-00098
• 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: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• 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 INERACTIVE ORTHOPEDIC SYSTEM (RIO)
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR