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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Arthralgia (2355)

Event Date 07/11/2014

Event Type  Injury  

Event Description

The patient had received a partial knee arthroplasty procedures using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.More than two years later, the patient complained of pain, and sought advice from a different surgeon.The surgeon determined that the pain was cause by a loose tibial implant.The surgeon performed a revision procedure, in which he removed the tibial and onlay insert component sand replaced them with components of the same size.During the revision procedure, the surgeon confirmed his theory that there was insufficient cement on the tibial baseplate for the implant to properly bond to the bone.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated at mako surgical.The most common cause of tibial baseplate loosening is an insufficient cement mantle, which was confirmed by the surgeon in this case.No bone was lost when the surgeon removed the implant, allowing him to replace it with a component of the same size.This further confirms the cause of the implant loosening.Adequate cementing technique guidelines are outlined in the makoplasty surgical technique guide: "multiple cement batches should be used when cementing multiple implants to maintain a consistent and suitable cement viscosity that enables all implants to fully mate to resected bone to ensure desired alignment, enables sufficient cement interdigitation in the cancellous bone to ensure proper fixation, and enables the user to apply an even distribution of compressive force to ensure the implant remains stable while the cement is setting." the surgical guide also suggests using a high pressure pulsed lavage or similar technique on the bone bed to remove fatty deposits from the cancellous porous structure.Prior to cementing, the surgical technique advises completely drying the bone bed to improve cement interdigitation.In addition, surgeon-led discussions take place at mako's bioskills training labs to ensure all mako users are aware of cementing best practices.

• Brand Name: TESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
• Type of Device: COMPARTMENTAL KNEE PROSTHESIS
• 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: 4017918
• MDR Text Key: 4711213
• Report Number: 3005985723-2014-00100
• Device Sequence Number: 1
• Product Code: HRY
• 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: 07/11/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 08/07/2014
• 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