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 Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly on or about (b)(6) 2021 the patient underwent a mako robotic assisted left medial unicompartmental knee arthroplasty.It is alleged on or about (b)(6) 2022, the tibial component had fractured and he underwent a total knee revision on (b)(6) 2022.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mako baseplate 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: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported through the filing of a lawsuit that allegedly on or about february 10, 2021 the patient underwent a mako robotic assisted left medial unicompartmental knee arthroplasty.It is alleged on or about (b)(6) 2022, the tibial component had fractured and he underwent a total knee revision on (b)(6) 2022.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
No new information.

• 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: 22468988
• Report Number: 3005985723-2025-00314
• Device Sequence Number: 7940463
• Product Code: NPJ
• UDI-Device Identifier: 00848486000721
• UDI-Public: 00848486000721
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2025

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 Expiration Date: 01/27/2025
• Device Catalogue Number: 180606
• Device Lot Number: 26281019-01
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2020
• 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: Male