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 Injury (2348); Joint Laxity (4526)

Event Date 05/26/2020

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

It was reported that the patient's left knee was revised due to instability.A 4 x 11 insert was revised to a 4 x 14 insert.Rep reported that no further information will be released.

Manufacturer Narrative

Reported event: it was reported that the patient's left knee was revised due to instability.A 4x11 insert was revised to a 4x14 insert.Rep reported that no further information will be released by the hospital or surgeon.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 associated with rob indicate that on 02/09/2015 quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn 209999 reports similar complaints for tka software - inaccurate resection.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 data, pre and post-operative x-rays, as well as patient history and follow-up notes 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.

Event Description

It was reported that the patient's left knee was revised due to instability.A 4x11 insert was revised to a 4x14 insert.Rep reported that no further information will be released.

• 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: 10105423
• MDR Text Key: 193060651
• Report Number: 3005985723-2020-00204
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR