MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED STEM BOWED

Lot Number	90762-005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	12/05/2023
Type of Reportable Event	Death
Event or Problem Description
Cancer patient.Patient experienced an embolism in canal after stem was cemented in femur.The patient crashed and passed away on the table during the surgery.
Additional Manufacturer Narrative
Based on the review of device history records, the investigation concluded that the root cause of this adverse event was not related to the design, manufacture, and/or sterilization of the eleos devices.The investigation concluded that intraoperative embolism is a procedure-related complication and is unrelated to the device.
Event or Problem Description
It was reported by h.Lewis, an onkos sales representative, that a female patient in her 70's terminally suffered from an intraoperative embolism during the primary surgery to implant an eleos proximal femur replacement on (b)(6) 2023.Bone cement was utilized to fixate the cemented segmental stem in the proximal femur.

• Brand Name: ELEOS
• Common Device Name: CEMENTED STEM BOWED
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: yara neurauter ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 18534753
• Report Number: 3013450937-2024-00012
• Device Sequence Number: 6751131
• Product Code: KRO
• UDI-Device Identifier: B278CB1515203M0
• UDI-Public: B278CB1515203M0
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/18/2024

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 Lot Number: 90762-005
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2023
• 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: 32MM FEMORAL HEAD +3.5 COCR - PLANNED USE; ELEOS 40MM MIDSECTION - PLANNED USE; RIGHT PROXIMAL FEMUR SEGMENT - PLANNED USE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR
• Patient Sex: Female