MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 1-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number	180701-1
Medical Device Problem Codes	Fitting Problem (2183); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2019
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The inner surface and edge of insert is not smooth, so it did not match with the baseplate pocket during the operation.The surgeon requested for same-sized, so same catalog number but different lot number insert was used.The new insert was fully seated on the baseplate without any problem.
Event or Problem Description
The inner surface and edge of insert is not smooth, so it did not match with the baseplate pocket during the operation.The surgeon requested for same-sized, so same catalog number but different lot number insert was used.The new insert was fully seated on the baseplate without any problem.
Additional Manufacturer Narrative
An event regarding assembly issue involving a mako inserter was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material evaluation and indicated the following comments: material analysis: damage observed on the insert consistent with contact against a hard object and attempted implantation and explantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the event could not be confirmed nor could the root cause be determined because the insufficient medical information was provided.Further information such as patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 1-8MM
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8289066
• Report Number: 3005985723-2019-00088
• Device Sequence Number: 1991802
• Product Code: NPJ
• UDI-Device Identifier: 00848486002015
• UDI-Public: 00848486002015
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 180701-1
• Device Lot Number: 12061117-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 01/06/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 04/22/2019
• 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
• Patient Age: 61 YR