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

Model Number 209999

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/01/2014

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 the 2014 patellofemoral joint replacement of the patient's left knee.As reported: "this principal investigator performed initial surgery and followed up with patient post-operatively.Information collected on patient reported: arthroscopy (2013) - patient experiencing pain, patellofemoral joint replacement (2014), arthroscopy (2014) - patient experiencing pain, locking, and giving way" patient had a restoris mck medial construct in situ at the time of event.

Event Description

This pi is for the 2014 patellofemoral joint replacement of the patient's left knee.As reported: "this principal investigator performed initial surgery and followed up with patient post-operatively.Information collected on patient reported: arthroscopy (2013) - patient experiencing pain, patellofemoral joint replacement (2014), arthroscopy (2014) - patient experiencing pain, locking, and giving way" patient had a restoris mck medial construct in situ at the time of event.

Manufacturer Narrative

Reported event: it was reported, " this pi is for the 2014 patellofemoral joint replacement of the patient's left knee.As reported: "this principal investigator performed initial surgery and followed up with patient post-operatively.Information collected on patient reported: arthroscopy (2013) - patient experiencing pain, patellofemoral joint replacement (2014), arthroscopy (2014) - patient experiencing pain, locking, and giving way" patient had a restoris mck medial construct in situ at the time of event.¿ product evaluation and results: review of the case session files was not performed as case session data was not provided.Product history review review of the device history records was not completed as the robot number/product information was not provided.Complaint history review a search of the complaint database under device identification pn 209999 reports no similar complaints for tka software - other.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data are needed to complete the investigation for determining root cause.Product surveillance will continue to monitor for trends.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.

• 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: 10225082
• MDR Text Key: 197341948
• Report Number: 3005985723-2020-00226
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention