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 Code	Insufficient Information (4580)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revised an left medial mck knee due to tibial baseplate implant fracture.He revised to a total knee.He said the patient didn't claim to have a traumatic event to particularly cause it.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mako baseplate was reported.The event was confirmed via evaluation of the returned device and clinician review of the provided medical records.Method & results: -product evaluation and results: visual inspection and material analysis: visual and stereo-microscope examination the images depicted in figure 1 show the (a) distal and (b) proximal side of the mck tibial baseplate and mako x3 uni onlay insert with fracture location of the tibial baseplate highlighted.Slight yellow discolouration consistent with oxidation, possibly a result of synovial fluid absorption, was observed on the insert "[1]".Stereo microscope imaging was performed on the mako x3 uni onlay insert, see figure 2(a ¿ b).Burnishing, scratching and third body indentations were observed on the articulating surface of the insert.Burnishing is caused by adhesive/abrasive wear of the insert against the femoral component.Scratching and indentations are caused by third body debris trapped between the insert and femoral component during articulating.Burnishing, scratching and third body indentations are consistent with commonly identified damage modes in uhmwpe inserts "[2]".Figure 3 (a ¿ b) shows stereo microscope images of the fracture surfaces of the mck tibial baseplate.Based on macroscopic surface features observed, including river lines, the approximate location of the fracture origin (o) was determined and labelled.Higher magnification images of the approximate location of fracture origin (o) are shown in figure 4(a ¿ b).Electron microscopy examination figure 5(a) shows a secondary electron image of the fracture surface of the mck baseplate, with fracture origin (o) highlighted.Figure 5(b) shows a higher magnification secondary electron image of the approximate region of fracture propagation associated with the mck baseplate component.The fracture propagated in fatigue as indicated by typical fatigue striations observed.Energy dispersive spectroscopy (eds) was performed on a representative area of the fracture surface of the mck baseplate to characterise the material composition (figure 6).Elemental constituents included titanium, aluminium and vanadium which are consistent with ti-6al-4v extra low interstitial alloy "[3]".Discussion & conclusion review of the mck tibial baseplate, catalogue # 180606, lot code 26110119-01, and mako x3 uni onlay insert, catalogue # 180736-1, lot code mh6nxe confirmed fracture of the mck baseplate.Characterisation using visual, stereo microscope, and secondary electron imaging confirmed fracture of the mck baseplate in fatigue.No manufacturing or material related defects were observed on the device surfaces examined." -clinician review: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: based on the pi report and the images provided, it appears that a fracture occurred through the metal of a tibial baseplate of a mck noncompartmental knee component.No medical history, labeled radiograph, operative notes or patient complaints were provided for review.The revision notes and/or radiographs were not provided for review.The fracture line was apparent on 3 differing presumed ct cuts.Event confirmation: metallic fracture (failure) of an mck unicompartmental tibial baseplate can be confirmed.Revision surgery cannot be confirmed but would be expected.Root cause: a rot cause for the tibial baseplate failure cannot be determined.The root cause of the unconfirmed revision surgery would be the baseplate fracture." -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 that the patient was revised due to fracture of the tibial baseplate and wear of the insert.A material analysis was performed on the returned devices which concluded the following: "review of the mck tibial baseplate, catalogue # 180606, lot code 26110119-01, and mako x3 uni onlay insert, catalogue # 180736-1, lot code mh6nxe confirmed fracture of the mck baseplate.Characterisation using visual, stereo microscope, and secondary electron imaging confirmed fracture of the mck baseplate in fatigue.No manufacturing or material related defects were observed on the device surfaces examined." a review of the provided medical records by a clinical consultant further confirmed the event but was unable to identify a root cause.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 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: deepan raju srinivasan ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23680169
• Report Number: 3005985723-2025-00559
• Device Sequence Number: 21259538
• Product Code: NPJ
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: 03/05/2024
• Device Catalogue Number: 180606
• Device Lot Number: 26110119-01
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2019
• 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: 56 YR
• Patient Sex: Male