MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Device Problems Migration or Expulsion of Device (1395); Osseointegration Problem (3003); Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

The surgeon had performed partial knee arthroplasty procedures using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants in (b)(6) 2013.The patient presented with pain during a follow up appointment.The surgeon performed an arthroscopy and discovered that the tibial baseplate was loose.The surgeon then decided to perform a revision to a total knee replacement.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has initiated at mako surgical.The investigation is ongoing, and a supplemental report will be filed when further 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 road; attn: william tapia; fort lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 4173225
• MDR Text Key: 5098945
• Report Number: 3005985723-2014-00147
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2014
• 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 INTERACTIVE ORTHOPEDIC SYSTEM (RIO)
• Patient Outcome(s): Required Intervention
• Patient Weight: 85