MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 9 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number	180735-2
Medical Device Problem Codes	Material Erosion (1214); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Insufficient Information (4580)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Device not returned.
Event or Problem Description
It was reported that the patient's right mako partial knee was revised due to medial subsidence of the femoral component, subsidence of the tibial component, and extreme poly wear.Surgeon stated the opinion that poly wear/ debris was a cause or contributor for femoral subsidence.Patient was revised to a total knee.Rep provided the original usage report and explant pictures.The devices are allegedly available for return, otherwise the rep confirmed that no further information will be released.
Event or Problem Description
It was reported that the patient's right mako partial knee was revised due to medial subsidence of the femoral component, subsidence of the tibial component, and extreme poly wear.Surgeon stated the opinion that poly wear/ debris was a cause or contributor for femoral subsidence.Patient was revised to a total knee.Rep provided the original usage report and explant pictures.The devices are allegedly available for return, otherwise the rep confirmed that no further information will be released.
Additional Manufacturer Narrative
Reported event.An event regarding subsidence involving a mako insert was reported.The event was confirmed.Method & results.-product evaluation and results: material evaluation was completed and indicated the following comments: wear damage on the articulating surface of the tibial insert is consistent with articulation against the femoral component.Material loss due to articulation was observed on the lateral side damage on the articulating surface of the tibial insert is consistent with articulation against the femoral component.Material loss due to articulation was observed on the lateral side of the implant.The xrf analyzes showed that the components were consistent with their respective drawings.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.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: material evaluation was indicated that damage on the articulating surface of the tibial insert is consistent with articulation against the femoral component.Material loss due to articulation was observed on the lateral side of the implant.The xrf analyzes showed that the components were consistent with their respective drawings.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 9 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: 10207270
• Report Number: 3005985723-2020-00223
• Device Sequence Number: 11423347
• Product Code: NPJ
• UDI-Device Identifier: 00848486016555
• UDI-Public: 00848486016555
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: 09/30/2020
• Device Model Number: 180735-2
• Device Catalogue Number: 180735-2
• Device Lot Number: 301KJV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 10/05/2020
• 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: 79 YR