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

Catalog Number 209999

Device Problem Insufficient Information (3190)

Patient Problems Aspiration/Inhalation (1725); Pain (1994)

Event Date 07/20/2020

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 patient 2 of 10.Surgeon reported he is experiencing a high complication rate with patients whose primary procedures were mako procedures.The nature of the 10 cases is unknown at the time of report.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.The nature of intervention for each of the 10 patients is unknown.

Manufacturer Narrative

Reported event: it was reported, "this pi is for patient 2 of 10.Surgeon reported he is experiencing a high complication rate with patients whose primary procedures were mako procedures.The nature of the 10 cases is unknown at the time of report.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.The nature of intervention for each of the 10 patients is unknown.Update 02/september/2020 wg: clinician review of additional information received indicates patient had a left knee aspiration of 15ml bloody fluid." product evaluation and results: review of the case session files was not performed as case session data was not provided.Clinician review: the available medical records were provided to the consulting clinician for a review which was rejected stating, this is the 2nd of 10 cases.(b)(6) 2019 implant labels triathlon: #3 left cr femur, #3 primary tibial baseplate, #3/9 x3 cs insert, 32/10 x3 asymmetric patella.Typed case history: mental health issues and multiple allergies.Left knee arthroscopy 2016, persistent pain.(b)(6)2019 left mako tka - "no complications".Post-operative persistent pain.(b)(6)2019 aspirated 15 ml hemarthrosis, (b)(6) 2019 arthroscopic lavage, synovial cauterization.(b)(6)2019 aspiration of 15 ml bloody fluid, 1 year post-op persistent pain and stiffness, (b)(6)2020 "no change in symptoms" no effusion, rom 0-105 degrees."no imaging studies, no operative reports, no laboratory reports.Based upon the information available for review, no confirmation of a correlation between the clinical course described and the mako procedure or instruments employed.Creation of a medical report is not possible for this case." product history review: a review of device history records shows that rob406 was inspected on 27 june 2016 and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn 209999, rob406 reports similar complaints for tka software ¿ other.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.A review of the provided medical records by a clinician indicated that: no imaging studies, no operative reports, no laboratory reports.Based upon the information available for review, no confirmation of a correlation between the clinical course described and the mako procedure or instruments employed.Creation of a medical report is not possible for this case.Further information such as return of the case session/log data, imaging studies, operative reports and laboratory reports are required to fully investigate the event.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.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no ncs or capas associated with the product and failure mode reported in this event.H3 other text : device not returned.

Event Description

This pi is for patient 2 of 10.Surgeon reported he is experiencing a high complication rate with patients whose primary procedures were mako procedures.The nature of the 10 cases is unknown at the time of report.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.The nature of intervention for each of the 10 patients is unknown.Update 02/september/2020 wg: clinician review of additional information received indicates patient had a left knee aspiration of 15ml bloody fluid.

• 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: 10396142
• MDR Text Key: 202548554
• Report Number: 3005985723-2020-00255
• Device Sequence Number: 1
• Product Code: OLO
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 74