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 Problem Discomfort (2330)

Event Date 03/04/2019

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 in the primary surgery.It was reported that the patient's left hip was revised due to the shell shifting and becoming anteverted.Surgeon confirmed shifting by comparing post-op x-rays from primary implant on (b)(6) 2019 and post-op x-rays in late (b)(6) 2019.Possible cause or contributor to shell shifting was not reported to rep.A shell, 2 screws, liner, biolox ceramic head and accolade ii stem were revised to a trident tritanium revision shell with 5 screws, an adm/mdm liner construct, lfit v40 metal head, and accolade ii stem.There are no allegations against the liner, head, or stem.Rep provided primary and revision implant sheets and reported no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: an event regarding revision 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 ((b)(4)) the complaint databases were reviewed from 2011 to present for similar reported events regarding revision.There were 8 other reported event for the listed catalog number ((b)(4)).-conclusion: product inspection could not be completed due to no logs or session files being released by the hospital or surgeon.H3 other text : evaluation could not be performed because the logs/session files were not provided.

Event Description

This pi is for the robot used in the primary surgery.It was reported that the patient's left hip was revised due to the shell shifting and becoming anteverted.Surgeon confirmed shifting by comparing post-op x-rays from primary implant on (b)(6), 2019 and post-op x-rays in late (b)(6) of 2019.Possible cause or contributor to shell shifting was not reported to rep.A shell, 2 screws, liner, biolox ceramic head and accolade ii stem were revised to a trident tritanium revision shell with 5 screws, an adm/mdm liner construct, lfit v40 metal head, and accolade ii stem.There are no allegations against the liner, head, or stem.Rep provided primary and revision implant sheets and reported no further information will be released by the hospital or surgeon.

• 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: 8425998
• MDR Text Key: 138970936
• Report Number: 3005985723-2019-00237
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 06/30/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR