MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	180735-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: mck femoral-rm-ll-sz 4, cat# 180514, lot# 231345k-1.Mck tibial baseplate-rm/ll-sz 5, cat# 180615, lot# 26240516-01.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Dr.(b)(6) revised a mako uni knee to a primary cementless tka due to pain.(b)(6) observed the patellafemoral joint disease progressed a bit.Implants were not loose.
Additional Manufacturer Narrative
An event regarding revision due to patient factors (disease progression) involving a mako insert was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: advanced degenerative disease in the patellofemoral compartment of a knee with a medial unicompartmental replacement is confirmed.Insufficient information has been received to confirm that this was progressive.No details of the revision surgery were provided.Product history review: indicated 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 lot referenced.Conclusion: advanced degenerative disease in the patellofemoral compartment of a knee with a medial unicompartmental replacement is confirmed.Insufficient information has been received to confirm that this was progressive.No details of the revision surgery were provided.Further information such as operative notes, pre and post operative x-rays, imaging from the index and revision surgeries as well as outpatient office and clinic notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Dr.(b)(6) revised a mako uni knee to a primary cementless tka due to pain.Marchand observed the patellafemoral joint disease progressed a bit.Implants were not loose.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM
• 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: 8065747
• Report Number: 3005985723-2018-00673
• Device Sequence Number: 11406889
• Product Code: NPJ
• UDI-Device Identifier: 00848486016548
• UDI-Public: 00848486016548
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 180735-1
• Device Lot Number: M063N8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/07/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR