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

Device Problems Material Erosion (1214); Insufficient Information (3190)

Patient Problems Injury (2348); Insufficient Information (4580)

Event Date 06/03/2020

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 197019538
• Report Number: 3005985723-2020-00223
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486016555
• UDI-Public: 00848486016555
• 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
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR