MAUDE Adverse Event Report: MAKO Surgical Corp. MAKO X3 UNI ONLAY TIB INS SIZE 3 - 8 MM; Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer

Catalog Number	180733-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Arthritis (1723)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Performing a revision of a uni knee to total knee procedure.Retrieval and removal of old tibia implant revealed a broken portion of the posterior polyethylene insert.Previous knee a mako pka performed on (b)(6) 2019.Revision was for advancement of arthritis and it was unknown there was any implant issue until the implant was removed.Total knee was implanted with no issues.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

• Brand Name: MAKO X3 UNI ONLAY TIB INS SIZE 3 - 8 MM
• Common Device Name: Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50195937
• Report Number: 3005985723-2026-00400
• Device Sequence Number: 15924590
• Product Code: HRY
• UDI-Device Identifier: 00848486016449
• UDI-Public: 00848486016449
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 09/30/2023
• Device Catalogue Number: 180733-1
• Device Lot Number: 9781YN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2018
• 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: 71 YR
• Patient Sex: Female