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

Model Number 180505

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 12/14/2013

Event Type  Injury  

Event Description

Surgeon was performing an exchange of a partial knee onlay insert component.During the procedure, the surgeon noticed that the femoral component seemed loose, so he revised the femoral component.

Manufacturer Narrative

As part of normal complaint follow-up, an eval of the event has been initiated at mako surgical.No report of infection was associated with the event.The likely cause of the femoral loosening is cementing technique.Proper cementing technique and known risks are indicated in the product literature.

Manufacturer Narrative

As part of normal complaint follow-up, an eval of the event has been initiated at mako surgical.No report of infection was associated with the event.The likely cause of the femoral loosening is cementing technique.Proper cementing technique and known risks are indicated in the product literature.

• Brand Name: RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
• Type of Device: PARITAL KNEE PROSTHESIS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie rd., suite 110; ft. lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie rd., suite 110; ft. lauderdale FL 33317
• Manufacturer Contact: william tapia ; 2555 davie rd., suite 110; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3581500
• MDR Text Key: 4062170
• Report Number: 3005985723-2014-00001
• 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: 12/14/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 180505
• Device Lot Number: 2143191-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR