MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209999

Device Problems Computer Software Problem (1112); Fracture (1260)

Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2018

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 the left knee.A completed medwatch form (not yet submitted to the fda) was provided by patient's attorney.That form reports "(b)(6) had bilateral mako unicompartmental knee arthroplasty.Placed, according to operative report, it was mako size 6 femur, size 7 tibia, 8 mm polyethylene insert.Pain continued after the implant.A visit to the er on february 17 had him sent back to his surgeon who did an x-ray which showed bilateral fractures of the medical condyles by the base plates.Mr.Porter required extensive surgery to remove and replace the implants".Additional information received by legal department: allegations: its alleged that the patient underwent bilateral mako partial knee replacements on (b)(6) 2018.Shortly after implantation, the patient began to experience pain in both knees.An er visit on (b)(6) 2018 revealed fractures by the baseplates.The patient's right knee was then revised on (b)(6) 2018 and his left knee was revised on (b)(6) 2018.

Event Description

This pi is for the left knee.A completed medwatch form (not yet submitted to the fda) was provided by patient's attorney.That form reports "mr.Porter had bilateral mako unicompartmental knee arthroplasty.Placed, according to operative report, it was mako size 6 femur, size 7 tibia, 8 mm polyethylene insert.Pain continued after the implant.A visit to the er on february 17 had him sent back to his surgeon who did an x-ray which showed bilateral fractures of the medical condyles by the base plates.Mr.Porter required extensive surgery to remove and replace the implants" additional information received by legal department: allegations: its alleged that the patient underwent bilateral mako partial knee replacements on (b)(6) 2018.Shortly after implantation, the patient began to experience pain in both knees.An er visit on (b)(6) 2018 revealed fractures by the baseplates.The patient's right knee was then revised on (b)(6)2018 and his left knee was revised on (b)(6) 2018.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a mako uni-baseplate was reported.The event was not confirmed.Methods & results: -product evaluation and results: not performed as the device was not returned.-clinician review: not performed as medical records were not provided for review.-product history review: a review of the device history records could not be performed as no lot information was provided.-complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8160296
• MDR Text Key: 130215130
• Report Number: 3005985723-2018-00734
• 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: other
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 111