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

Model Number 219999

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/20/2021

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: "i received some information regarding a surgeon out of (b)(6) who is an avid mako supporter and user.He expressed some concerns over press-fit femoral fit".Case 2: femur loosening was observed.

Manufacturer Narrative

Reported event.An event regarding inaccurate resection involving a mako tka software was reported.The event was not confirmed because the product was not available for inspection.Method & results.-product evaluation and results: review of the case session files was not performed as case session data was not provided.No response received from the mps.No response from the software team when a request was made regarding the flash drive mentioned at intake.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that rob1033 was inspected on 12 nov 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: rob1033 shows 0 similar complaints for tka software - inaccurate resection.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data are needed to complete the investigation for determining root cause.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Device not returned.

Event Description

As reported: "i received some information regarding a surgeon out of knoxville, tn who is an avid mako supporter and user.He expressed some concerns over press-fit femoral fit".Case 2: femur loosening was observed.

• 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: 11334810
• MDR Text Key: 232091191
• Report Number: 3005985723-2021-00017
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• 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
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization