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 Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

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 implant.As reported in (b)(4): "mako partial knee required a revision to a total knee." update 18/march/2019: "spoke to rep.Patient was revised due to tibial collapse.Surgeon reported the patient did not follow medical advice post-operatively and built a barn.The unusual forces involved caused the failure.There are no allegations against any stryker devices or procedures.Rep reported that no further information will be released by the hospital or surgeon.".

Manufacturer Narrative

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 (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding a revision.There were 40 other reported events (b)(4).Conclusion: product inspection could not be performed because no further information will be released by the hospital or surgeon h3 other text : product was not available for evaluation.

Event Description

This pi is for the robot used in the primary implant.As reported in pi (b)(4): "mako partial knee required a revision to a total knee.Update 18/march/2019: spoke to rep.Patient was revised due to tibial collapse.Surgeon reported the patient did not follow medical advice post-operatively and built a barn.The unusual forces involved caused the failure.There are no allegations against any stryker devices or procedures.Rep reported that 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: 8449575
• MDR Text Key: 139757030
• Report Number: 3005985723-2019-00260
• 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

• Date FDA Received: 03/25/2019
• 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
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR