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

Model Number 209999

Device Problems Computer Software Problem (1112); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348)

Event Date 02/26/2018

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 right knee.A completed medwatch form (not yet submitted to the fda) was provided by patient's attorney.That form reports "mr.(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 (b)(6) 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.(b)(6) required extensive surgery to remove and replace the implants" additional information received by legal department: allegations: it's 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 right knee.A completed medwatch form (not yet submitted to the fda) was provided by patient's attorney.That form reports "mr.(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 (b)(6) 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.(b)(6) 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 incorrect landmark selected involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported a completed medwatch form (not yet submitted to the fda) was provided by patient's attorney.That form reports "mr.(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 (b)(6) 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.(b)(6) required extensive surgery to remove and replace the implants".Method & results: product evaluation and results: not performed as case session data was not provided.Product history review: a review of the device history records could not be performed as the robot serial number was not reported.Complaint history review: a search of the complaint database under device identification pn: 209999 reports similar complaints for pka software - software error.The complaint record numbers are: (b)(4).Conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.No additional investigation or specific actions are required at this time.If additional information is received such as the session files, then the complaint will be reopened.Corrective action/preventive action: a search of the nc/capa database under device identification pn: 209999 reports no records related to pka software - software error.

Manufacturer Narrative

Update to conclusion.Reported event.An event regarding periprosthetic fracture involving a mako pka software was reported.The event was confirmed via medical review.Method & results.-product evaluation and results: review of the case session files was not performed as case session data was not provided.-clinician review: a review of the provided medical information by a clinical consultant indicated: no examination of the explanted components, no operative reports of the open reduction internal fixation procedures of the tibial plateau fractures, and no follow-up subsequent to august 23, 2018 is available for review.In this large, obese male patient with bilateral long-standing osteoarthritis of the knees with bilateral varus deformities not corrected by bilateral medial unicompartmental knee arthroplasties, the indication for unicompartmental knee arthroplasties is questionable.The surgical pathology report of the left knee revision seven weeks after the unicompartmental knee surgery noted "knee fragments" from the other two compartments of the left knee as "consistent with osteoarthritis", which would also question the initial indication for unicompartmental knee arthroplasty in this patient.The post-operative varus position of the knees as well as the subluxation indication acl insufficiency and arthritis in the other knee compartments all resulted in excessive force generate across the medial uka which resulted in the inevitable fatigue fracture of the medial tibial plateau.This clinical situation was unlikely related to the material, design, or manufacturing of the unicompartmental components implanted in this patient.-product history review: a review of device history records was not completed as the robot was not identified.-complaint history review: a complaint history review was not completed at the robot number was not provided.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: no examination of the explanted components, no operative reports of the open reduction internal fixation procedures of the tibial plateau fractures, and no follow-up subsequent to august 23, 2018 is available for review.In this large, obese male patient with bilateral long-standing osteoarthritis of the knees with bilateral varus deformities not corrected by bilateral medial unicompartmental knee arthroplasties, the indication for unicompartmental knee arthroplasties is questionable.The surgical pathology report of the left knee revision seven weeks after the unicompartmental knee surgery noted "knee fragments" from the other two compartments of the left knee as "consistent with osteoarthritis", which would also question the initial indication for unicompartmental knee arthroplasty in this patient.The post-operative varus position of the knees as well as the subluxation indication acl insufficiency and arthritis in the other knee compartments all resulted in excessive force generate across the medial uka which resulted in the inevitable fatigue fracture of the medial tibial plateau.This clinical situation was unlikely related to the material, design, or manufacturing of the unicompartmental components implanted in this patient.Device not available.

Event Description

This pi is for the right 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.

• 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: 8202678
• MDR Text Key: 131611359
• Report Number: 3005985723-2018-00794
• 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,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 111