MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 219999

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/19/2020

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

This pi is for the closed reduction on (b)(6) 2020.As reported: "pt discharged to inpatient rehab (b)(6) 2020.On (b)(6) 2020 pt out of bed unassisted, bent over to pick something up off floor and felt sharp pain in hip.Xray showed dislocation, pt taken to or for closed reduction.Pt discharged home (b)(6) 2020.On (b)(6) 2020 pt presented to emergency department with complaint of hip pain & swelling - pt admitted w/ cellulitis.Pt to operating room (b)(6) 2020 for i&d - positive wound culture - deep surgical site infection.Pt left against medical advice post-op.".

Manufacturer Narrative

Reported event: an event regarding dislocation involving a mako tha software was reported.The event was confirmed through clinician review of the provided medical records.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: confirmation: the events: dislocation, i and d, and wound infection appear confirmed.Root cause: the root cause of the dislocation cannot be confirmed without additional records and x-rays.It is unclear why a mako ct was obtained without a mako procedure.The infection is likely related to the significant comorbid conditions of the patient.The events appear unrelated to the implants.Product history review: a review of device history records shows that (b)(6) was inspected on 30 aug 2019 and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: (b)(6) shows 1 similar complaints for tha software - other.Conclusions: the alleged failure mode was confirmed via review of the returned medical records by a clinician however the root cause cannot be confirmed based on the information provided.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the log/session files, operative reports, progress notes and x-rays are needed to complete the investigation for determining root cause.H3 other text : device not returned.

Event Description

This pi is for the closed reduction on (b)(6) 2020.As reported: "pt discharged to inpatient rehab (b)(6) 2020.(b)(6) 2020 pt out of bed unassisted, bent over to pick something up off floor and felt sharp pain in hip.Xray showed dislocation, pt taken to or for closed reduction.Pt discharged home (b)(6) 2020.(b)(6) 2020 pt presented to emergency department with complaint of hip pain & swelling - pt admitted w/ cellulitis.Pt to operating room (b)(6) 2020 for i&d - positive wound culture - deep surgical site infection.Pt left against medical advice post-op.".

• Brand Name: MAKO ROBOTIC ARM 3.1
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 11118053
• MDR Text Key: 225155937
• Report Number: 3005985723-2021-00006
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 219999
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR