MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 219999

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/16/2020

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

It was reported through the submission of a revision usage sheet that the patient's right knee was revised.Rep stated: "patient came through er with wound issues.Was brought into surgery for i&d and swap of liner.Removal implant/x-rays not available.".

Manufacturer Narrative

Reported event: an event regarding infection involving a mako tka robot/software was reported.The event was not confirmed.Method & results: product evaluation and results: review of the case session files was not performed as case session data was not provided.Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob880 was inspected on 13 feb 2019 and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: rob880 shows 0 similar complaints for tka software - other (patient factors).Conclusions: an event regarding revision due to patient factors involving a mako robot/tka software was reported.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 : device not returned.

Event Description

It was reported through the submission of a revision usage sheet that the patient's right knee was revised.Rep stated: "patient came through er with wound issues.Was brought into surgery for i&d and swap of liner.Removal implant/x-rays not available.".

• Brand Name: MAKO ROBOTIC ARM 3.1
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10828803
• MDR Text Key: 215900132
• Report Number: 3005985723-2020-00357
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 219999
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR