MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL HINGE COMPONENT

Model Number	25002100E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the patient undergoing a revision surgery due to an alleged infection was unable to be definitively determined.The patient's medical history is unknown.There is always a chance of a patient developing an infection from an invasive surgical procedure such as limb salvage surgery.However, the risk is justified as the alternative in many cases would be amputation of the limb.Device history records and sterilization batch release records were reviewed and no issues during manufacturing or sterilization were identified that would indicate that the manufacturing or sterilization of the involved implants contributed to this complaint.
Event or Problem Description
A patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to an alleged infection.During the revision, the surgeon explanted the following components that contained poly: the tibial poly spacer, the distal femur axial pin, and the tibial baseplate.The surgeon also performed a washout of the infected area.

• Brand Name: ELEOS
• Common Device Name: TIBIAL HINGE COMPONENT
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11870517
• Report Number: 3013450937-2021-00094
• Device Sequence Number: 3202643
• Product Code: KRO
• UDI-Device Identifier: B27825002100E0
• UDI-Public: B27825002100E0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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: 03/23/2026
• Device Model Number: 25002100E
• Device Catalogue Number: 25002100E
• Device Lot Number: 1736285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR