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

Model Number 209999

Device Problems Loss of Osseointegration (2408); Output Problem (3005)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

As part of the 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

Pi for the robot, rob 276, that was used in the primary surgery for the patient in (b)(4). Revision of a restoris medial unicompartment knee to a total knee replacement with mr (b)(6) at (b)(6) hospital. Patient had a revision undertaken due to pain upon walking. Femoral component appeared well fixed, tibial component was easily moved during the revision. Once implants were removed the tibial implant showed no visible signs of bonding to the cement nor the bone. Femur was well fixed. A total knee replacement was completed satisfactorily using a triathlon ps implant, without delay.

Event Description

Pi for the robot, (b)(6) , that was used in the primary surgery for the patient in (b)(6). Revision of a restoris medial unicompartment knee to a total knee replacement with mr cooper at joondalup hospital. Patient had a revision undertaken due to pain upon walking. Femoral component appeared well fixed, tibial component was easily moved during the revision. Once implants were removed the tibial implant showed no visible signs of bonding to the cement nor the bone. Femur was well fixed. A total knee replacement was completed satisfactorily using a triathlon ps implant, without delay.

Manufacturer Narrative

Reported event: an event regarding revision due to pain/loosening involving 3. 0 rio® robotic arm - mics, catalog: 209999 was reported. It was reported, ¿pi for the robot, rob 276, that was used in the primary surgery for the patient in pi 2158967. Revision of a restoris medial unicompartment knee to a total knee replacement with mr. At joondalup hospital. Patient had a revision undertaken due to pain upon walking. Femoral component appeared well fixed, tibial component was easily moved during the revision. Once implants were removed the tibial implant showed no visible signs of bonding to the cement nor the bone. Femur was well fixed. A total knee replacement was completed satisfactorily using a triathlon ps implant, without delay. ¿ product evaluation and results: not performed as case session data was not provided. -clinician review: a review of the provided medical records by a clinical consultant stated the following comment: rejected for medical review [. ] ¿ cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history. Product history review review of the device history records associated with rio 276 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 tka software - other (revision due to pain/loosening) 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 tka software - other (revision due to pain/loosening) h3 other text : device not returned.

• 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: 9100866
• Report Number: 3005985723-2019-00685
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Weight: 105
• Patient Outcome(s): Other