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 07/27/2020

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

As reported: "pt brought to emergency department due to leg swelling after a fall at home.Obvious shortening of leg noted in emergency department, xray showed hip dislocation and pt admitted.Pt return to or (b)(6) 2020 for hip revision.Pt discharged to.Rehab.".

Manufacturer Narrative

Reported event: an event regarding dislocation involving a mako tha software application was reported.The dislocation 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 records by a clinical consultant stated the following comment: confirmation: the event was confirmed, there was a dislocation that led to revision surgery.Root cause: additional medical records and in particular radiographs would be required to ascertain a root cause.Based on the provided material the dislocation was likely the result of a combination of implant mal-position, patient cognitive factors and/or trauma.The root cause did not appear to be implant related.Product history review: a review of device history records shows that rob987 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: rob987 shows 1 similar complaints for tha software - other(dislocation).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.

Event Description

As reported: "pt brought to emergency department due to leg swelling after a fall at home.Obvious shortening of leg noted in emergency department, xray showed hip dislocation and pt admitted.Pt return to or (b)(6) 2020 for hip revision.Pt discharged to.Rehab.".

• 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: 11118035
• MDR Text Key: 225112729
• Report Number: 3005985723-2021-00005
• 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: 04/15/2021

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: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR