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 Unspecified Infection (1930)

Event Date 01/07/2019

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 procedure.Dr.(b)(6) explanted a right knee stryker mako tka implants originally done on (b)(6) 2018 due to infection and put in a cement spacer.The infection he felt was due to the patient falling post-op and tearing the patellar tendon.Update 09/january/2018: rep provided the usage sheet from the primary and reported that no further information is available from the hospital.

Event Description

This pi is for the robot used in the primary procedure.Dr.(b)(6) explanted a right knee stryker mako tka implants originally done on (b)(6) 2018 due to infection and put in a cement spacer.The infection he felt was due to the patient falling post-op and tearing the patellar tendon.Update 09/january/2018: rep provided the usage sheet from the primary and reported that no further information is available from the hospital.

Manufacturer Narrative

Reported event: an event regarding revision due to infection was reported.Method & results: device history review: a review of the dhr associated with rio 119 found quality inspection procedures successfully passed.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding revision of a total knee procedure due to infection.There were no other similar reported events for the listed catalog number.Conclusion: product inspection could not be completed because x-rays, medical records, and additional supplementary information are not available due to hospital policy.

• 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: 8239705
• MDR Text Key: 132793704
• Report Number: 3005985723-2019-00045
• 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: 04/19/2019

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: 01/07/2019
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR