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

Model Number 180704-1

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 04/17/2014

Event Type  Injury  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been conducted by mako surgical.The rio case session files were reviewed, and all values are within acceptable tolerances.Evidence suggests that the rio performed as intended to place the implants according to the implant plan.The pt exhibited disease progression in the pf region of the knee.Osteophyte growth has historically contributed to pain in the joint.The evaluation is ongoing, and supplemental report will be filed if additional info or conclusions are obtained.

Event Description

The surgeon had performed a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee implants on (b)(6) 2012.The surgeon said the pt never really did well and always complained of pain.The pt had a manipulation performed on (b)(6) 2012.The pt was unable to take anti-inflammatories.On the date of event, the surgeon performed a total knee revision procedure.Upon opening the knee during the revision procedure, the surgeon noticed some osteophytes on the lateral facet of the patellofemoral (pf) joint.When the onlay insert was extracted, there was a noticeable wear pattern on the antero-medial region.

• Brand Name: RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
• Type of Device: COMPARTMENTAL KNEE PROSTHESIS
• Manufacturer (Section D): MAKO SURGICAL CORP.; ft. lauderdale FL
• Manufacturer Contact: jonathan reeves ; 2555 davie rd.; ft. lauderdale, FL 33317 ; 9546280665
• MDR Report Key: 3835963
• MDR Text Key: 21167451
• Report Number: 3005985723-2014-00057
• 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: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 180704-1
• Device Lot Number: 12310112-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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)
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR