MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO® THA SOFTWARE APPLICATION; STEREOTACTIC DEVICE, ACCESSORY

Catalog Number 205634

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2015

Event Type  malfunction  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

The surgeon was performing a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).The inclination value readout was higher than planned after impaction as discovered on post-op x-ray.The outcome of the case was successful and there was no harm to the patient.

Manufacturer Narrative

Follow-up #1 and final report to update based on the results of investigation.Reported event: an event regarding inclination higher than planned, involving a tha 2.1 rio tha software application, catalog: 205634 was reported.Method & results: device evaluation and results: device inspection could not be performed, no session data was provided.Per mps, "patient info was not released".Device history review:a review of the dhr could not be performed.Serial number for system used was not provided.Reported event is in reference to software.Complaint history: (b)(4).

Event Description

The surgeon was performing a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).The inclination value readout was higher than planned after impaction as discovered on post-op x-ray.The outcome of the case was successful and there was no harm to the patient.

• Brand Name: RIO® THA SOFTWARE APPLICATION
• Type of Device: STEREOTACTIC DEVICE, ACCESSORY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: jonathan reeves ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 5240361
• MDR Text Key: 31761366
• Report Number: 3005985723-2015-00272
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 205634
• Device Lot Number: THA 2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR