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

Catalog Number	180614
Medical Device Problem Codes	Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Codes	Subluxation (4525); Insufficient Information (4580)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.H3 other text : device not returned.
Event or Problem Description
Planned revision surgery.Patient presented at 2 year follow up appointment with x-ray showing the uni tibial baseplate had subsided.During the revision surgery from a medial uni to total knee the tibial and femoral components appeared to be we well fixated to bone.They were removed with minimal or no bone loss and a primary triathlon knee was implanted.
Additional Manufacturer Narrative
Reported event: an event regarding subsidence involving a mako baseplate was reported.The event was not confirmed.Method & results: -product evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs show a femoral component, tibial baseplate, and insert that have been recently explanted and are covered in blood.There appears to be some cement adhered to the bone-interfacing sides of the devices.Explantation damage is visible on the insert as well as yellow discoloration consistent with absorption of synovial fluid.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this case concerns a patient who underwent a primary medial unicompartmental knee arthroplasty then developed what the surgeon felt to be subsidence of the tibial component.At revision surgery tibia and femoral components were well fixed.A revision was carried out.I can confirm that the patient had the primary procedure since i was able to see an x-ray showing the unicompartmental knee arthroplasty.I cannot confirm the revision since i have no documentation except the date of explant with no operation report, office notes or post revision x-rays.Causes of subsidence with subsequent need for revision surgery are multifactorial including initial surgical technique, ligament balancing, restoration of kinematics, alignment and positioning as well as cement technique.Also factors include the patient's activity level and bmi.With the information provided i would not assign any causality to the implant itself." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported 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 subsidence of the tibial baseplate.Clinician review of the provided medical records was unable to confirm the event.Further information such as pathology reports, additional pre- and post-operative x-rays and the revision 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Planned revision surgery.Patient presented at 2 year follow up appointment with x-ray showing the uni tibial baseplate had subsided.During the revision surgery from a medial uni to total knee the tibial and femoral components appeared to be we well fixated to bone.They were removed with minimal or no bone loss and a primary triathlon knee was implanted.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18070532
• Report Number: 3005985723-2023-00168
• Device Sequence Number: 7815056
• Product Code: NPJ
• UDI-Device Identifier: 00848486000776
• UDI-Public: 00848486000776
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: 07/08/2024
• Device Catalogue Number: 180614
• Device Lot Number: 26040619-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 11/04/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 76 KG