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
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 6949853
• Report Number: 0002249697-2017-03013
• Device Sequence Number: 1209088
• Product Code: NPJ
• UDI-Device Identifier: 00848486000752
• UDI-Public: 00848486000752
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other