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

Device Problems Fitting Problem (2183); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2019

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.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 134493942
• Report Number: 3005985723-2019-00088
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486002015
• UDI-Public: 00848486002015
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR