MAUDE Adverse Event Report: MAKO Surgical Corp. MCK TIBIAL BASEPLATE-LM/RL-SZ 3; Prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, poly

Catalog Number	180603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Due to factors such as the use of high-viscosity bone cement during implantation, the surgeon applied excessive impaction, resulting in a fracture of the tibial condyle.The procedure was completed by switching to total knee arthroplasty (tka).

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 3
• Common Device Name: Prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, poly
• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50251866
• Report Number: 3005985723-2026-00416
• Device Sequence Number: 10070660
• Product Code: NPJ
• UDI-Device Identifier: 00848486000691
• UDI-Public: 00848486000691
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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 Catalogue Number: 180603
• Device Lot Number: J61673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/14/2026
• 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 Sex: Unknown