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

Catalog Number 209999

Device Problems Computer Software Problem (1112); Non Reproducible Results (4029)

Patient Problems Discomfort (2330); Injury (2348)

Event Date 09/11/2018

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

It was reported that patient's right hip was revised due to dislocation.A 40 mm stryker ceramic head and mako lipped liner were revised to a 32 mm ceramic head and competitor liner cemented into existing shell.Rep provided some pre-revision x-rays and reported that additional x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

Reported event: an event regarding revision due to dislocation involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 154 found quality inspection procedures successfully passed.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 two other reported event for the listed catalog number ((b)(4)).Conclusion: product inspection could not be completed due to no logs or session files not being available due to hospital policy.Device not returned.

Event Description

It was reported that patient's right hip was revised due to dislocation.A 40mm stryker ceramic head and mako lipped liner were revised to a 32mm ceramic head and competitor liner cemented into existing shell.Rep provided some pre-revision x-rays and reported that additional x-rays, medical records, and further 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: 7920122
• MDR Text Key: 122103024
• Report Number: 3005985723-2018-00558
• 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: 12/26/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 79