MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 3-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180703-1

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

A surgeon revised a bilateral mako mck medial uni knee patient, originally done (b)(6) 2014 to bilateral triathlon cementless total knee due to an acrylic allergy and disease progression.Surgeon used competitor cement in primary procedure on (b)(6) 2014.

Manufacturer Narrative

An event regarding revision due to patient factors (acrylic allergy and disease progression) involving a mako insert was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review.Further information such as medical confirmation of presence of acrylic allergy & confirmation of the date of the x-rays are needed for completion of the assesment.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that patient was revised due to an acrylic allergy and disease progression.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.The provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review.No further investigation for this event is possible at this time.Further information such as return of the device, medical confirmation of presence of acrylic allergy & confirmation of the date of the x-rays are needed to investigate this event further.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

A surgeon revised a bilateral mako mck medial uni knee patient, originally done (b)(6) 2014 to bilateral triathlon cementless total knee due to an acrylic allergy and disease progression.Surgeon used competitor cement in primary procedure on (b)(6) 2014.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 3-8MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6827708
• MDR Text Key: 83888987
• Report Number: 3005985723-2017-00405
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2019
• Device Catalogue Number: 180703-1
• Device Lot Number: 12180514-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR