MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 7; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180617

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

A size 2 pka tibia in a size 7 box.

Manufacturer Narrative

An event regarding label mix involving a mako baseplate was reported.The event was confirmed.An image was provided of the product box, product label and device.The outer label of the implant box does not match the label of the implant sticker or the device.The device and implant sticker product information matches.No medical records were received for review with a clinical consultant.Review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There has been one other event for the lot referenced visual inspection of the implant box, implant sticker and product image confirmed that the outer label of the implant box does not match the label of the implant sticker and device.Nc has been raised to investigate the event.It was identified that the most likely root cause was due to improper line clearance during the printing process.

Event Description

A size 2 pka tibia in a size 7 box.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 7
• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7149041
• MDR Text Key: 96008459
• Report Number: 0002249697-2017-03711
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 180617
• Device Lot Number: 26150217-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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