MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS STEM EXTENSION - CEMENTED

Model Number	KSC01530E
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 cemented stem extension.
Additional Manufacturer Narrative
It was reported on (b)(6) 2022 that a patient underwent a revision surgery on (b)(6) 2022 due to an alleged infection.The surgeon removed and replaced the distal femur, axial pin, tibial hinge component, cemented segmental stem, male-female midsection, tibial baseplate, two tibial block augments, cemented stem extension, and a poly spacer.The patient's original surgery date is unknown, therefore, the product information of the implants that were implanted at the time of the infection is unknown.Additional information regarding this event was not available.A review of the work orders and sterilization batch release records could not be completed due to lack of product information.The root cause of this complaint could not be determined.

• Brand Name: ELEOS
• Common Device Name: ELEOS STEM EXTENSION - CEMENTED
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC; 5677 airline rd; arlington NC 38002
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 14120786
• Report Number: 3013450937-2022-00130
• Device Sequence Number: 11335497
• Product Code: KRO
• UDI-Device Identifier: B278KSC01530E0
• UDI-Public: B278KSC01530E0
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: KSC01530E
• Device Catalogue Number: KSC01530E
• 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
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 06/16/2022
• 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; 25001212E ELEOS POLY SPACER; 25002111E ELEOS AXIAL PIN; CS-17120-03M ELEOS SEGMENTAL STEM - 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