MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 6; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	180606
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994); Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "pka revision (restoris), when removing tibial baseplate was snapped in half.The surgeon thinks it snapped when he removed it with an osteotome but is unsure if was already cracked insitu.".

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 6
• 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): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 24681661
• Report Number: 3005985723-2026-00139
• Device Sequence Number: 10003980
• Product Code: NPJ
• UDI-Device Identifier: 00848486000721
• UDI-Public: 00848486000721
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2026

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: 11/24/2021
• Device Catalogue Number: 180606
• Device Lot Number: 26130816-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2016
• 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: 71 YR
• Patient Sex: Male