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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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.Device not returned.
 
Event Description
This pi is for patient 3 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.
 
Event Description
This pi is for patient 3 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 01/september/2020: as reported by clinician review, patient had an arthroscopic debridement of adhesions of her left knee on (b)(6) 2020.
 
Manufacturer Narrative
Reported event: it was reported, "this pi is for patient 3 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 01/september/2020: as reported by clinician review, patient had an arthroscopic debridement of adhesions of her left knee on (b)(6) 2020.".Product evaluation and results: review of the case session files was not performed as case session data was not provided.Clinician review: typed case history: long history of left knee pain and previous surgeries.(b)(6) 2019 left mako tka "no complications" post-op course continued pain and swelling.Manipulation 9/17/19.Arthroscopic debridement of adhesions 11/19/19 and 7/13/20.The available medical records were provided to the consulting clinician for a review which was rejected stating, "no imaging studies, no operative reports, no surgical pathology reports.Based upon the information supplied, no correlation of the clinical course described with the mako procedure or instruments can be confirmed nor a medical report created 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.
 
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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 Key10404450
MDR Text Key202808593
Report Number3005985723-2020-00267
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
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 Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number209999
Device Lot NumberROB406
Was Device Available for Evaluation? No
Date Manufacturer Received10/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient Weight68
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