MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS PST/TFS TOTAL HIP SYSTEM; ARTIFICIAL TOTAL HIP REPLACEMENT

Model Number 186004-04

Device Problems Crack (1135); Noise, Audible (3273)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/14/2014

Event Type  Injury  

Event Description

On the date of event, the surgeon had performed a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio) and the restoris pst/tfs total hip system.In conversation a few weeks later, mako was informed that a small calcar crack occurred during broaching.The surgeon placed a cerclage wire and continued broaching.The surgeon struggled to broach and noted that the patient had very hard bone.An intraoperative x-ray was taken to evaluate the femur because the surgeon could not get past the size 2 broach, when a size 4 stem was planned.The surgeon used some of the specialized tools in the pst instrument set to continue broaching, and placed the implants.Subsequently, the scrub tech noted that the hip made a popping sound.The surgeon ordered another x-ray, and noted a femoral fracture near the lesser trochanter.The surgeon then removed the psi stem, and placed a stryker restoration stem with a cerclage wire.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event was initiated at mako surgical.The surgeon stated that the patient has recovered nicely.The evaluation is ongoing, and a supplemental report will be submitted when results are obtained.

• Brand Name: RESTORIS PST/TFS TOTAL HIP SYSTEM
• Type of Device: ARTIFICIAL TOTAL HIP REPLACEMENT
• Manufacturer (Section D): MAKO SURGICAL; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd.; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3804539
• MDR Text Key: 15111946
• Report Number: 3005985723-2014-00051
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112802
• 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: 04/07/2014

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: 11/30/2018
• Device Model Number: 186004-04
• Device Lot Number: 100083-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2014
• Initial Date FDA Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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: 58 YR
• Patient Weight: 91