MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 2; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180612

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicates the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

After implanting the components, we were reviewing the usage form and saw that the implant box said tibial baseplate size 2rm/ll and the implant sticker said, "7rm/ll".The implant was the correct size and we were able to finish without any issues.Pka procedure.

Manufacturer Narrative

An event regarding label mix involving a mako baseplate was reported.The event was confirmed.Device evaluation and results: the implant box and the implant sticker (patient label) were returned intact.The outer label of the implant box does not match the label of the implant sticker.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced conclusions: visual inspection of the returned implant box and the implant sticker confirmed that the outer label of the implant box does not match the label of the implant sticker.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

After implanting the components, we were reviewing the usage form and saw that the implant box said tibial baseplate size 2rm/ll and the implant sticker said, "7rm/ll".The implant was the correct size and we were able to finish without any issues.Pka procedure.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 2
• 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: 6949853
• MDR Text Key: 90181055
• Report Number: 0002249697-2017-03013
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000752
• UDI-Public: 00848486000752
• 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: 11/30/2017

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: 05/30/2022
• Device Catalogue Number: 180612
• Device Lot Number: 26080317-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 11/01/2017
• Supplement Dates FDA Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2017
• 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