MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 2; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	180602
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient who had the surgery of makomck on (b)(6) 2025 will have a revision surgery on (b)(6) 2025 due to tibial subsidence.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event an event regarding malposition involving a mako baseplate was reported.The event was confirmed via clinician review of the provided medical records.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: a review of the provided medical records by a clinical consultant indicated: 'i can confirm that the patient underwent a primary medial unicompartmental knee arthroplasty and that the tibial component changed position and the patient underwent revision surgery.I can do so because there were x-rays that i was able to review.I cannot confirm the dates.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of shift in position of a tibial component approximately six weeks following the index surgery are multifactorial but, in most cases, this would be related to surgical technique in the way the implant is positioned and initially cemented in place.Trauma can play a role but no trauma was mentioned.Other factors including the patients activity level, lifestyle and bmi can also be considered but i would doubt those factors play a role at six weeks.Given the information provided, i would not assign any causality to the implant itself.' -device 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 reported lot.Conclusions: it was reported that 'the patient who had the surgery of makomck on (b)(6)2025 will have a revision surgery on (b)(6)2025 due to tibial subsidence.' a review of the provided medical records by a clinical consultant indicated: 'i can confirm that the patient underwent a primary medial unicompartmental knee arthroplasty and that the tibial component changed position and the patient underwent revision surgery.I can do so because there were x-rays that i was able to review.I cannot confirm the dates.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of shift in position of a tibial component approximately six weeks following the index surgery are multifactorial but, in most cases, this would be related to surgical technique in the way the implant is positioned and initially cemented in place.Trauma can play a role but no trauma was mentioned.Other factors including the patients activity level, lifestyle and bmi can also be considered but i would doubt those factors play a role at six weeks.Given the information provided, i would not assign any causality to the implant itself.' no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 2
• 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: deepan raju srinivasan ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23851178
• Report Number: 3005985723-2025-00626
• Device Sequence Number: 15852802
• Product Code: NPJ
• 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: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 180602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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