MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 1; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number 180611

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

Patient Problems Pain (1994); Injury (2348); Joint Disorder (2373)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: mako x3 uni onlay tibial insert size 1 - 9 mm; cat# 180731-2; lot# ml2a63.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Sales rep reported a revision of a left uni knee due to pain.

Manufacturer Narrative

Additional information: lot #, expiration date; manufacturing date.An event regarding pain & revision involving an mako baseplate was reported.The event was not confirmed.Visual, dimensional and functional inspection were not performed as the item was not returned.The provide medical records were submitted to a clinical consultant who indicated: "the patient experienced progression of her primary disease-osteoarthritis ¿ in the medial aspect of her knee.Surgeons records indicate this level of medial disease was not present prior to the pkr.No xrays were available for review.There is no evidence for defect in the implants or their manufacture." review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There has been no other event for this lot.The event could not be confirmed nor the root cause determined since insufficient information was provided.A review of the provided medical records by a clinical consultant indicated that the patient experienced progression of her primary disease-osteoarthritis ¿ in the medial aspect of her knee but the surgeons records indicate this level of medial disease was not present prior to the pkr and there is no evidence for defect in the implants or their manufacture.A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.Further information such as return of device, pre- and post-op xrays, office notes, operative reports, patient history, histopathology report & follow-up notes are needed to investigate this event further.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Sales rep reported a revision of a left uni knee due to pain.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 1
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• 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: 6607587
• MDR Text Key: 76509303
• Report Number: 3005985723-2017-00241
• 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: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2019
• Device Catalogue Number: 180611
• Device Lot Number: 26161213-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2014
• 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: 62 YR
• Patient Weight: 72