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 Problem Pain (1994)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplement al report will be submitted when additional information becomes available.

Event Description

This pi is for patient 1 of 3.(b)(6) yo male, surgery (b)(6) 201 9.As reported by surgeon: attached are xrays of three patients i previously discussed.All have concerning radiolucencies underneath the tibial baseplate that appeared several months post op.Thus far, none have required revision but all have some degree of pain (mostly medial).Again i never saw this prior the mics transition.Let me know your thoughts and if any other surgeons have seen this issue.More recently, i have been using a 2mm drill to perforate the sclerotic tibial surface to promote better cement interdigitation and my results seem to be much better.Case type: pka 3.0.

Manufacturer Narrative

Update to d2.Reported event: it was reported ¿this pi is for patient 1 of 3.As reported by surgeon: attached are xrays of three patients i previously discussed.All have concerning radiolucencies underneath the tibial baseplate that appeared several months post op.Thus far, none have required revision but all have some degree of pain (mostly medial).Again i never saw this prior the mics transition.Let me know your thoughts and if any other surgeons have seen this issue.More recently, i have been using a 2mm drill to perforate the sclerotic tibial surface to promote better cement interdigitation and my results seem to be much better.Case type: pka 3.0.¿ method & results: product evaluation and results: a review of the case logs did not find anything that would suggest issue with the robotic system.The patient plan and resection visuals did not show anything out of the ordinary.All accuracy values for bone registration were acceptable and the registration pattern was properly taken.Product history review: a review of device history records shows that (b)(6) was inspected on (b)(6) 2009 and was handled via npr.A review of the data revealed that the non-conformances is not related to the failure alleged in this complaint.Complaint history review: a search of the complaint database under device identification pn: 209999 reports no similar complaints for pka software, other.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.A review of the case logs did not find anything that would suggest issue with the robotic system.The patient plan and resection visuals did not show anything out of the ordinary.All accuracy values for bone registration were acceptable and the registration pattern was properly taken.No additional investigation or specific actions are required at this time.If additional information is received, then the complaint will be reopened.System is ready for use.

Event Description

This pi is for patient 1 of 3.As reported by surgeon: attached are xrays of three patients i previously discussed.All have concerning radiolucence es underneath the tibial baseplate that appeared several months post op.Thus far, none have required revision but all have some degree of pain (mostly medial).Again i never saw this prior the mics transition.Let me know your thoughts and if any other surgeons have seen this issue.More recently, i have been using a 2mm drill to perforate the sclerotic tibial surface to promote better cement interdigitation n and my results seem to be much better.Case type: pka 3.0.

• 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: 9779802
• MDR Text Key: 181843065
• Report Number: 3005985723-2020-00124
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• 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: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR