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

Model Number	25002112E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with onkos devices on (b)(6) 2022.An onkos custom adaptor was created to connect to the patient's previously existing hardware to the onkos distal femur replacement system.It was reported that a patient was revised on (b)(6) 2022 due to an infection.The following implanted devices were removed during the revision procedure: custom compress adaptor, eleos tibial hinge, eleos tibial poly spacer, eleos tibial baseplate, eleos tibial baseplate tapered screw, two eleos male-female midsections, eleos distal femur axial pin, eleos distal femur, and an eleos tibial baseplate.This record captures the eleos distal femur axial pin.This event will be reported to the fda as a serious injury.
Event or Problem Description
A patient was implanted with onkos devices on (b)(6) 2022.The patient was implanted with eleos proximal tibia replacement system.It was reported that the patient was revised on (b)(6) 2022 due to an infection.The following implanted devices were removed during the revision procedure: eleos poly spacer, eleos proximal tibia, eleos cemented stem, eleos tibial hing component, eleos resurfacing femur axial pin, eleos stem extension, eleos resurfacing femur, eleos resurfacing femur tapered screw.This event will be reported to the fda as a serious injury due to the revision surgery.This record captures the eleos resurfacing femur axial pin.
Additional Manufacturer Narrative
Section b5 and section d4-6 were corrected due to incorrect initial reporting.Event description, device information and codes were updated to reflect new information received on 03 august 2022.The patient was implanted with the eleos proximal tibia replacement on (b)(6) 2022.On (b)(6) 2022, the patient underwent their original eleos surgery where the following implants were extracted due to infection: eleos proximal tibia, eleos tibial poly spacer, eleos resurfacing femur, eleos resurfacing femur axial pin, eleos resurfacing femur tapered screw, eleos canal filling stem extension, eleos straight cemented stem, and eleos tibial hinge component.An antibiotic spacer was placed after the implants were removed.The cause identified for this complaint is an alleged infection, which required surgical intervention.Ultimately, the root cause of the patient's infection was unable to be determined.Based upon the device history records, sterilization records, and interview with the sales representative the investigation concluded that the root cause of the alleged infection is not related to the design, manufacture, and/or sterilization of the components.

• Brand Name: ELEOS
• Common Device Name: RESURFACING FEMUR AXIAL PIN
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey ed; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 14649419
• Report Number: 3013450937-2022-00174
• Device Sequence Number: 14846419
• Product Code: KRO
• UDI-Device Identifier: B27825002112E0
• UDI-Public: B27825002112E0
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 09/01/2022

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: 06/16/2021
• Device Model Number: 25002112E
• Device Catalogue Number: 25002112E
• Device Lot Number: 1888413
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2021
• 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 Age: 55 YR
• Patient Sex: Female