MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED STEM EXTENSION, 14X65MM, STRAIGHT

Model Number	KSC01465E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery due to an alleged infection.During the revision surgery, the following eleos implants were revised: tibial hinge component, distal femur axial pin, and poly spacer.The following eleos implants remain implanted from the patient's original procedure: stem extension, segmental stem, distal femur, male-female midsection, and tibial baseplate.No additional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2023-00177, #3013450937-2023-00178, #3013450937-2023-00179, #3013450937-2023-00181, #3013450937-2023-00182, #3013450937-2023-00183, #3013450937-2023-00184.

• Brand Name: ELEOS
• Common Device Name: CEMENTED STEM EXTENSION, 14X65MM, STRAIGHT
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline rd; arlington TN 38002
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17619630
• Report Number: 3013450937-2023-00180
• Device Sequence Number: 7302297
• Product Code: KRO
• UDI-Device Identifier: B278KSC01465E0
• UDI-Public: B278KSC01465E0
• 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 Implanted Year: 2023
• 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): 08/24/2023

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: KSC01465E
• Device Catalogue Number: KSC01465E
• Device Lot Number: 1866005
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2020
• 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: P/N 25000007E, ELEOS DISTAL FEMUR.; P/N 25001040E, ELEOS MALE FEMALE MIDSECTION.; P/N 25001208E, ELEOS POLY SPACER.; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN.; P/N CS-13120-03M, ELEOS SEGMENTAL STEM.; P/N TB-2203E-01M, ELEOS TIBIAL BASEPLATE.; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Unknown