MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 4-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number	180704-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.Catalog numbers and lot codes of other devices listed in this report: 180614 mck tibial baseplate-rm/ll-sz 4 lot 26120816-01 180513 mck femoral-rm-ll-sz 3 lot 498154-m it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It has reported "an mri had to be stopped because of severe knee pain and the patient has not experienced any problem on that knee area after surgery.The patient underwent unicondylar prosthesis placement in the medial compartment of the right knee using robotic surgery".Post-operative infection and adverse conditions after surgery.The product is implanted in the patient and not explanted.
Additional Manufacturer Narrative
Reported event an event regarding infection involving a mako insert was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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.There have been no other similar events for the sterile lot referenced.Conclusions: it was reported that the patient had severe knee pain and post-operative infection.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It has reported "an mri had to be stopped because of severe knee pain and the patient has not experienced any problem on that knee area after surgery.The patient underwent unicondylar prosthesis placement in the medial compartment of the right knee using robotic surgery".Post-operative infection and adverse conditions after surgery.The product is implanted in the patient and not explanted.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 4-8MM
• Common Device Name: 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12502276
• Report Number: 3005985723-2021-00160
• Device Sequence Number: 3255404
• Product Code: NPJ
• UDI-Device Identifier: 00848486000882
• UDI-Public: 00848486000882
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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: 05/23/2021
• Device Model Number: 180704-1
• Device Catalogue Number: 180704-1
• Device Lot Number: 12210416-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 64 KG