MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number	180604
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left medial uni knee was revised due to the tibial baseplate breaking in half (no cause or contributor to the breakage was reported to the rep).The insert became damaged/ warped as a result.The patient was converted to a tka with stem and augments.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mako baseplate was reported.The event was confirmed via clinician review and product evaluation.Method & results: product evaluation and results: characterisation using visual, stereo microscope, and secondary electron imaging confirmed fracture of the mck baseplate in fatigue with final fracture in overload.No manufacturing or material related defects were observed on the examined areas of the components.Clinician review: a review of medical records with a clinical consultant indicated "i can confirm that the patient underwent a unicompartmental knee arthroplasty since i was able to review an x-ray with the implant in place if only a lateral view.I can also confirm that the patient developed a fracture of the tibial base plate, which was visible on the x-rays provided.The event description stated that the patient underwent revision surgery to convert the uni to a total knee arthroplasty, however, i cannot confirm this since i have no documentation such as doctors notes, post revision, x-rays, or operation note, other than that statement.Root cause analysis: the root cause of this event, tibial baseplate fracture in a unicompartmental knee arthroplasty, cannot be determined with certainty.The causes of baseplate fracture are multifactorial, including surgical technique, especially in the positioning, alignment and fixation of the implant, as well as the restoration of proper kinematics of the knee.Other contributing causes could be patient related, including lifestyle, activity level, and bmi, as well as implant factors.Product history review: review of the device history records indicate the devices were manufactured and accepted into final stock on with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: characterisation using visual, stereo microscope, and secondary electron imaging confirmed fracture of the mck baseplate in fatigue with final fracture in overload.No manufacturing or material related defects were observed on the examined areas of the components.A review of medical records with a clinical consultant indicated "i can confirm that the patient underwent a unicompartmental knee arthroplasty since i was able to review an x-ray with the implant in place if only a lateral view.I can also confirm that the patient developed a fracture of the tibial base plate, which was visible on the x-rays provided.The event description stated that the patient underwent revision surgery to convert the uni to a total knee arthroplasty, however, i cannot confirm this since i have no documentation such as doctors notes, post revision, x-rays, or operation note, other than that statement.Root cause analysis: the root cause of this event, tibial baseplate fracture in a unicompartmental knee arthroplasty, cannot be determined with certainty.The causes of baseplate fracture are multifactorial, including surgical technique, especially in the positioning, alignment and fixation of the implant, as well as the restoration of proper kinematics of the knee.Other contributing causes could be patient related, including lifestyle, activity level, and bmi, as well as implant factors.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.
Event or Problem Description
No new information.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 4
• 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: deepan raju srinivasan ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23036275
• Report Number: 3005985723-2025-00423
• Device Sequence Number: 9207701
• Product Code: NPJ
• UDI-Device Identifier: 00848486000707
• UDI-Public: 00848486000707
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 180604
• Device Lot Number: MS00730719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2020
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 100 KG