MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); Injury (2348); Inadequate Osseointegration (2646)

Event Date 02/19/2020

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 procedure.As reported in (b)(4): "doctor revised a triathlon pa beaded femoral component size 3 to a cemented size 2 primary cr femur.He also swapped the tibial insert.He did this due to patient stiffness.He said the implant wasn't grossly loose, but noted the distal and posterior interface was mostly fibrous ingrowth.He did note the original x-ray, it looked like the femur may have been flexed slightly relative to the cuts which caused a slight gap in certain areas.Right knee." rep provided primary and revision usage sheets and reported that no further information will be released by the hospital or surgeon.

Event Description

This pi is for the robot used in the primary procedure.As reported in (b)(4): "doctor revised a triathlon pa beaded femoral component size 3 to a cemented size 2 primary cr femur.He also swapped the tibial insert.He did this due to patient stiffness.He said the implant wasn't grossly loose, but noted the distal and posterior interface was mostly fibrous ingrowth.He did note the original x-ray, it looked like the femur may have been flexed slightly relative to the cuts which caused a slight gap in certain areas.Right knee." rep provided primary and revision usage sheets and reported that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding rom and loosening involving a mako tka case was reported.The event was not confirmed.It was reported that ¿this pi is for the robot used in the primary procedure.As reported in (b)(4): "dr.Revised a triathlon pa beaded femoral component size 3 to a cemented size 2 primary cr femur.He also swapped the tibial insert.He did this due to patient stiffness.He said the implant wasn't grossly loose, but noted the distal and posterior interface was mostly fibrous ingrowth.He did note the original x-ray, it looked like the femur may have been flexed slightly relative to the cuts which caused a slight gap in certain areas.Right knee." rep provided primary and revision usage sheets and reported that no further information will be released by the hospital or surgeon.¿ product evaluation and results: review of the case session files was not performed as case session data was not provided.Clinician review was not performed as no medical records were received for review with a clinical consultant.Product history review: review of the device history records associated with (b)(6) indicate that on 29/nov/2010 quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn: 209999, (b)(6) reports no similar complaints for tka software inaccurate resection.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session data, pre and post-operative x-rays, as well as patient history and follow-up notes are needed to complete the investigation for determining root cause no additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text : device not returned.

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9837064
• MDR Text Key: 183772342
• Report Number: 3005985723-2020-00159
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR