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

Model Number 209999

Device Problems Computer Software Problem (1112); Migration (4003)

Patient Problems Pain (1994); Tissue Damage (2104)

Event Date 07/01/2019

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

Mako uni revised for aseptic loosening of tibial component.Revised to tka.This complaint is for the robot (b)(4).

Event Description

Mako uni revised for aseptic loosening of tibial component.Revised to tka.This complaint is for the robot (b)(4).

Manufacturer Narrative

Reported event: an event regarding implant loosening (subsidence) involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported that the ¿mako uni revised for aseptic loosening of tibial component.Revised to tka.Product evaluation and results: not performed as case session data was not provided.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: regarding the referenced pis, this case represents a male patient.The event description states, ¿mako uni revised for aseptic loosening of tibial component.Revised to tka.¿ the date of the implant is listed as (b)(6) 2018 and the date of explant is listed as 07/01/19.No operative reports are available but the listed components for the uni are an mck tibial baseplate lm/rl size 5, mck femoral lm/rl size 4, and mck tibial on-lay insert size 5/8mm.It was implanted using a 3.0 rio robotic arm-mics.X-ray printouts available for review include a series dated october 23, 2018, which is an ap and lateral of the left knee, demonstrating a cemented left medial uni-compartmental knee arthroplasty, reduced and in nominal position.The host bone appears osteoporotic.X-rays dated may 1, 2019 are two ap¿s and one lateral of the left knee demonstrating the tibial component subsided into osteoporotic bone of the tibial plateau.No clinical or past medical history, no operative reports, no patient demographics and no examination of explanted components are available.Initial post-operative x-rays demonstrate a nominally placed left medial uni-compartmental knee arthroplasty into osteoporotic bone.Six months later x-rays demonstrate subsidence of the tibial component into the porotic tibial plateau.There is no evidence either the components or the robotic device were responsible for this clinical event.-product history review: review of the device history records associated with rio 275 indicate quality inspection procedures were completed with no reported discrepancies.-complaint history review: a search of the complaint database under device identification pn 209999 reports no similar complaints for pka software - other.Conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.No additional investigation or specific actions are required at this time.If additional information is received such as the session files, then the complaint will be reopened.Corrective action/preventive action: a search of the nc/capa database under device identification pn 209999 reports no records related to pka software - other.

• 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: 8760039
• MDR Text Key: 150004305
• Report Number: 3005985723-2019-00493
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other