MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 4-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180704-1

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There has been one other similar event for the lot referenced which occurred during the same procedure for the same patient.Material analysis: damage observed on insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

During the final stage of the case the surgeon was attempting to place the poly.He was concerned about the poly not sitting down on the lateral side of the base plate.After several attempts to get the poly to seat, i had someone run and grab a second poly.We opened that and had the same issue.I noticed that the new poly shared a lot code with the original.When we could not get the second poly with the same lot code to seat, we opened a third implant that had a different lot code.This poly went in and sat on the tray like it should.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 4-8MM
• 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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8209741
• MDR Text Key: 131853452
• Report Number: 3005985723-2019-00012
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000882
• UDI-Public: 00848486000882
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 180704-1
• Device Lot Number: 12181017-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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): Other