MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Model Number 180615

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Arthralgia (2355)

Event Date 05/29/2014

Event Type  Injury  

Event Description

A surgeon had performed a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.Almost three years after the surgery, the patient returned to the hospital complaining of persistent pain in the knee.An x-ray was taken, and the x-ray image revealed loosening of the tibial component.The surgeon (not the original surgeon who performed the initial makoplasty procedure) determined that the proper course of action was to revise the patient to a total knee replacement.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated at mako surgical.The surgeon noted good implant placement and cement adhesion, as observed during the revision procedure.The surgeon also noted potential premature wear of the insert onlay component, which was not related to the patient's pain.Photographs of the insert were reviewed, but the component was not available for return to mako surgical.Further review of the event is ongoing, and supplemental report will be filed if results are obtained.

• Brand Name: RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
• Type of Device: COMPARTMENTAL KNEE PROSTHESIS
• Manufacturer (Section D): MAKO SURGICAL; ft. lauderdale FL
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie rd., suite 110; ft. lauderdale FL 33317
• Manufacturer Contact: william tapia ; 2555 davie road; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3918841
• MDR Text Key: 4668267
• Report Number: 3005985723-2014-00082
• 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: 05/29/2014

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: 05/31/2016
• Device Model Number: 180615
• Device Lot Number: 26090211-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2014
• Initial Date FDA Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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