MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209999

Device Problems Loss of or Failure to Bond (1068); Output Problem (3005)

Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2018

Event Type  Injury  

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

This pi is for the robot used for navigation in the primary procedure.It was reported that patient's left hip was revised due a periprosthetic femoral fracture and stem subsidence after patient fell.The securfit advanced stem, biolox 32 +0 head, and 32mm 0° c liner were revised to a competitor modular stem construct and femoral head with a stryker adm/mdm liner construct and 4 cable and sleeve sets.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.

Manufacturer Narrative

Reported event: an event regarding revision due to loosened implant involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: -device history review: not performed as the device being inspected is software.Rio serial number not reported.-complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding revision.There were 6 other reported event for the listed catalog number (pr1442085, pr1737869, pr1898251, pr1930169, pr1950907, and pr1962866).-conclusion: product inspection could not be completed due to no logs or session files not being available from hospital or surgeon.

Event Description

This pi is for the robot used for navigation in the primary procedure.It was reported that patient's left hip was revised due a periprosthetic femoral fracture and stem subsidence after patient fell.The securfit advanced stem, biolox 32 +0 head, and 32mm 0° c liner were revised to a competitor modular stem construct and femoral head with a stryker adm/mdm liner construct and 4 cable and sleeve sets.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8135193
• MDR Text Key: 129395309
• Report Number: 3005985723-2018-00723
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• PMA/PMN Number: K170593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

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: No Information
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 61