MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 9 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180734-2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding pain involving a mako insert was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: the available medical records were provided to the consulting clinician for a review which was rejected for medical review stating," no clinical or pmh, no operative reports, no imaging studies to review.Based upon the information submitted, neither confirmation of the event descriptions nor preparation of a medical report is possible for this case.Based on review of the additional records the clinician noted that ," based upon the additional information, insufficient data still is not available to confirm the event descriptions nor prepare a medical report for this case." 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: it was reported that the patient's right knee had pain.The available medical records were provided to the consulting clinician for a review which was deemed insufficient to confirm the event.The event could not be confirmed nor the root cause be determined because insufficient medical information was provided.Further information such as medical documentation and returned devices are needed.The patient wanted to know if the device was part of recall, based on the review of stryker database it is noted that the device is not part of any recall.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.The following devices were also listed in this report: mck femoral-rm-ll-sz 5; 180515 ;529564m.Mck tibial baseplate-rm/ll-sz 4; 180614 ; 2662081701.Simplex p - us full dose 10-pk; 61911010;rcz041.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

Event Description

The patient had bilateral tka done on (b)(6) 2018.Patient has been experiencing pain on both knees since her surgery.Patient has had physical therapy for about 6 weeks.The patient stated her pain has been consistent and has never been the same since her surgery.Patient had left knee x-ray done on (b)(6) 2020 and as per her surgeon the results show her left knee is narrowing.She would like to know if her implants are part of recall and is seeking compensation.This pi is for the right knee.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 11236856
• MDR Text Key: 228908373
• Report Number: 3005985723-2021-00012
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486016500
• UDI-Public: 00848486016500
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2021

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: 04/30/2023
• Device Model Number: 180734-2
• Device Catalogue Number: 180734-2
• Device Lot Number: Y9487W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other