MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS POLY SPACER

Model Number	25001212E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised on (b)(6) 2022 due to an alleged infection.The patient underwent a polyswap procedure.The following implants were revised: eleos distal femur, axial pin, tibial hinge component, segmental stem - cemented, male-female midsection, tibial baseplate, two tibial augments, stem extension - cemented, and a poly spacer.This event will be reportable as a serious injury due to revision surgery.This record captures the eleos tibial polyspacer.

• Brand Name: ELEOS
• Common Device Name: ELEOS POLY SPACER
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC; 5677 airline rd; arlington TN 38002
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 14120788
• Report Number: 3013450937-2022-00131
• Device Sequence Number: 2291735
• Product Code: KRO
• UDI-Device Identifier: B27825001212E0
• UDI-Public: B27825001212E0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 04/15/2022

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 Model Number: 25001212E
• Device Catalogue Number: 25001212E
• 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: 03/17/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 25000007E ELEOS DISTAL FEMUR; 25001040E ELEOS MALE-FEMALE MIDSECTION; 25002111E ELEOS AXIAL PIN; CS-17120-03M ELEOS SEGMENTAL STEM - CEMENTED; KSC01530E ELEOS STEM EXTENSION - CEMENTED; KTAGB505E ELEOS TIBIAL AUGMENT; KTAGB505E ELEOS TIBIAL AUGMENT; TB-2205E-01M ELEOS TIBIAL BASEPLATE; THSMWRS01M ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Unknown