MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; RESURFACING FEMUR AXIAL PIN

Lot Number	1857439
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of this complaint was not determined.Based on a review of device history records, the investigation concluded that the root cause of the alleged infection was not related to the design, manufacture, and/or sterilization of the explanted devices.
Event or Problem Description
It was reported by (b)(6), an onkos sales representative, that a 78-year-old male patient with an eleos hinge knee replacement underwent revision surgery due to an alleged infection.The revision surgery was performed by dr.(b)(6) on (b)(6) 2024.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: RESURFACING FEMUR AXIAL PIN
• 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: 20907769
• Report Number: 3013450937-2024-00371
• Device Sequence Number: 17173756
• Product Code: KRO
• UDI-Device Identifier: B27825002114E0
• UDI-Public: B27825002114E0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 12/11/2024

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: 1857439
• 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: 11/11/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2020
• 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: RESURFACING FEMUR AXIAL PIN; TIBIAL POLY SPACER; TIBIAL ROTATIONAL HINGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male