MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number 180737-1

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.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

As reported: "during the case there was an issue with the first 7x8mm tibial poly used as the poly would not lock into place properly.A second 7x8 poly was opened and locked into place using same technique with no issues on first try".Rep confirmed a surgical delay of 1 minute.

Event Description

As reported: "during the case there was an issue with the first 7x8mm tibial poly used as the poly would not lock into place properly.A second 7x8 poly was opened and locked into place using same technique with no issues on first try".Rep confirmed a surgical delay of 1 minute.

Manufacturer Narrative

An event regarding seating/locking issue involving a mako insert was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection of the returned device indicates there are a number of scratches on the surfaces of the device consistent with attempted implantation and explantation damage.Material analysis: damage observed on the insert consistent with attempted implantation.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.Conclusion: one insert was returned for evaluation.There are scratches on the surfaces of the insert consistent with attempted implantation and explantation damage.The event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as images of the device taken when the alleged event was identified is required to complete the investigation for confirming the event and determining a root cause.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 8 MM
• 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: 7780539
• MDR Text Key: 117293641
• Report Number: 3005985723-2018-00485
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486016647
• UDI-Public: 00848486016647
• Combination Product (y/n): N
• PMA/PMN Number: K150307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 180737-1
• Device Lot Number: 9H75XE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Date Manufacturer Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR