MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 2; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	180602
Medical Device Problem Codes	Degraded (1153); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Performing a uni to total revision knee for anterior knee pain.Patient has a lateral right lateral mck uni insitu performed in 2017 by doctor via mako.During revision, poly insert was extracted and found to have evidence of wear/oxidation.Tibia baseplate was also found to be loose.Surgeon reported potentially a pain contributor.Pain was mainly patella femoral however.Also polyethylene unable to see lot and size.Mako tka 2.0.
Additional Manufacturer Narrative
Reported event.An event regarding loosening involving a mako baseplate was reported.The event was not confirmed.Method & results.Product evaluation and results: visual inspection of the returned device indicated bone cement attached to the baseplate damage present consistent with the time it was implanted.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 that the patient's partial uni knee was revised to total revision knee for anterior knee pain.During revision, tibia baseplate was also found to be loose.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining 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.
Event or Problem Description
No new information.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 2
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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 ; 2018315000
• MDR Report Key: 22635965
• Report Number: 3005985723-2025-00341
• Device Sequence Number: 15492660
• Product Code: OLO
• UDI-Device Identifier: 00848486000684
• UDI-Public: 00848486000684
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 03/31/2020
• Device Catalogue Number: 180602
• Device Lot Number: 26560115
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2015
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 65 KG