MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; RESURFACING FEMUR AXIAL PIN

Model Number	25002113E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent revision surgery on (b)(6) 2022 due to an alleged infection.The patient's index surgery occured on (b)(6) 2021 where the patient was implanted with the following implants: eleos proximal tibia, eleos resurfacing femur axial pin, eleos poly spacer, eleos tibial hinge, eleos segmental stem, eleos stem extension, and eleos resurfacing femur.During the revision procedure, the eleos proximal tibia, eleos resurfacing femur axial pin, eleos poly spacer, and eleos tibial hinge were removed and replaced.This event will be reportable to the fda as a serious injury, as the patient underwent a revision procedure.All the devices implanted at the time of infection will be reported.This report captures the eleos resurfacing femur axial pin.
Additional Manufacturer Narrative
It was reported that a patient developed an alleged infection and underwent a revision surgery on (b)(6) 2022.During the revision surgery, the surgeon revised the following implants: proximal tibia, resurfacing femur axial pin, tibial poly spacer, and tibial hinge component.The following eleos implants remain implanted from the patient's original surgery on (b)(6) 2021: cemented straight segmental stem, stem extension, and resurfacing femur.A review of the work orders and sterilization batch release records for the products involved found no indication that the alleged infection was a result of a manufacturing or sterilization nonconformance.The root cause identified for this complaint is an alleged infection, which required surgical intervention.The root cause of the patient's alleged infection could not be determined.The following mdrs have been submitted for this event: 3013450937-2022-00339, 3013450937-2022-00340, 3013450937-2022-00341, 3013450937-2022-00342 , 3013450937-2022-00343 , 3013450937-2022-00344 , 3013450937-2022-00345.

• Brand Name: ELEOS
• Common Device Name: RESURFACING FEMUR AXIAL PIN
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey road; parsippany, NJ 07054
• MDR Report Key: 15826513
• Report Number: 3013450937-2022-00340
• Device Sequence Number: 20372753
• Product Code: KRO
• UDI-Device Identifier: B27825002113E0
• UDI-Public: B27825002113E0
• 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: 2021
• 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): 02/17/2023

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: 25002113E
• Device Catalogue Number: 25002113E
• Device Lot Number: 1802762
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2019
• 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