MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO UKR X3 ONLAY INSERT SIZE 3 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	180733-1-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: mck femoral-lm-rl-sz 3; cat# 180503; lot# unknown, mck tibial baseplate-lm/rl-sz 3; cat# 180603; lot# unknown, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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 was not returned.-clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the lot details were not provided.Complaint history review: could not be performed as the lot details were not provided.Conclusions: it was reported that the patient was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with 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 was reported that the patient's knee was revised.As reported: "the pt had some wound drainage that might indicate initial infection.Dr.Wanted to do an i&d &,swap out the poly insert with the identical size that was removed." rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: MAKO UKR X3 ONLAY INSERT SIZE 3 - 8 MM
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21081314
• Report Number: 3005985723-2025-00004
• Device Sequence Number: 12487464
• Product Code: NPJ
• UDI-Device Identifier: 07613327385892
• UDI-Public: 07613327385892
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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 Catalogue Number: 180733-1-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2024
• Initial Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female