MAUDE Adverse Event Report: ONKOS SURGICAL INC ELEOS; TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP

Model Number	25002100E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported their knee feeling loose.Upon imaging, it was identified that the post of the patient's eleos tibial hinge component had broken off.The patient underwent a revision procedure to remove and replace the patient's eleos tibial hinge component on (b)(6) 2022.During the revision procedure, the surgeon also revised the patient's distal femur axial pin and poly spacer; however, there were no alleged issues reported with these two devices.This event will be reportable to the fda as a serious injury as the patient underwent a revision procedure.
Additional Manufacturer Narrative
It was reported that a patient's knee felt 'loose', due to the implanted tibial hinge component fracturing at the post.Subsequently, the patient underwent revision surgery on (b)(6) 2022.During the patient's revision surgery, the following implants were revised: poly spacer, resurfacing femur axial pin, and tibial hinge component.No issues were reported for the poly spacer nor resurfacing femur axial pin.Therefore, these devices are concomitant.Additional details regarding the patient's compliancy, external trauma, and post-operative activity levels are not known.Device history records were reviewed and no issues were identified.The root cause for the tibial hinge post fracture could not be identified for this complaint as additional information regarding the event is not known.

• Brand Name: ELEOS
• Common Device Name: TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP
• Manufacturer (Section D): ONKOS SURGICAL INC; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey road; parsippany, NJ 07054
• MDR Report Key: 15853658
• Report Number: 3013450937-2022-00347
• Device Sequence Number: 6525312
• Product Code: KRO
• UDI-Device Identifier: B27825002100E0
• UDI-Public: B27825002100E0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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 Model Number: 25002100E
• Device Catalogue Number: 25002100E
• Device Lot Number: 1802640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2019
• 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
• Patient Sex: Male