MAUDE Adverse Event Report: ONKOS SURGICAL INC ELEOS; STEM EXTENSION, CEMENTED 18MM X 100MM

Model Number	KSC18100E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision procedure due to an alleged infection.The patient was initially implanted on (b)(6) 2022 with the following eleos implants: stem extension, resurfacing axial pin, straight cemented stem, resurfacing femur, proximal tibia, tibial hinge w/ rotational stop, resurfacing femur tapered screw, and a poly spacer.On (b)(6) 2022 the patient was revised to remove and replace the axial pin, tibial hinge, and poly spacer.The remaining devices were left implanted in the patient.This event will be reportable to the fda as a serious injury due to revision procedure.All devices which were implanted at the time of the alleged infection will be reported.This record captures the eleos stem extension.
Additional Manufacturer Narrative
It was reported that the patient developed an alleged infected and underwent a revision surgery on (b)(6) 2022.During the revision surgery, the surgeon revised the following implants: eleos resurfacing femur axial pin, eleos tibial hinge component and eleos tibial poly spacer.The following eleos implants remain implanted from the patient's original surgery on (b)(6) 2022: cemented stem extension, cemented segmental stem, resurfacing femur, proximal tibia, and resurfacing femur tapered screw.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 of the patient's alleged infection could not be determined.The following mdrs were submitted for all the devices implanted at the time of patient's infection: 3013450937-2022-00316, 3013450937-2022-00317, 3013450937-2022-00318 , 3013450937-2022-00319, 3013450937-2022-00320, 3013450937-2022-00321, 3013450937-2022-00322.

• Brand Name: ELEOS
• Common Device Name: STEM EXTENSION, CEMENTED 18MM X 100MM
• Manufacturer (Section D): ONKOS SURGICAL INC; 77 e halsey rd; pasippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 15711908
• Report Number: 3013450937-2022-00315
• Device Sequence Number: 20488444
• Product Code: KRO
• UDI-Device Identifier: B278KSC18100E0
• UDI-Public: B278KSC18100E0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 01/27/2023

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
• Device Model Number: KSC18100E
• Device Catalogue Number: KSC18100E
• Device Lot Number: 1785489
• 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: 10/02/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2018
• 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: 70 YR
• Patient Sex: Male