MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; TIBIAL BASEPLATE

Lot Number	P231175-019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an onkos sales representative, that a patient with eleos distal femur replacement underwent revision surgery due to joint dislocation.This report captures eleos tibial baseplate.This event will be reported as a serious injury due to the revision procedure.
Additional Manufacturer Narrative
The root cause of this complaint was not determined.Based on the review of known 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 revised implants.
Event or Problem Description
It was reported by t.Langer, an onkos distributor, that a 63-year-old female patient with an eleos distal femur replacement underwent revision surgery on (b)(6) 2025 due to a dislocation.The patient's surgical wound reportedly dehisced (opened) upon standing from a seated position.
Additional Manufacturer Narrative
The investigation concluded that the root cause of the reported dislocation was not related to the design, manufacture, and/or sterilization of the explanted devices.The most probable root cause of the reported adverse event is soft tissue laxity.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: TIBIAL BASEPLATE
• 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: 23547725
• Report Number: 3013450937-2025-00341
• Device Sequence Number: 9327014
• Product Code: KRO
• UDI-Device Identifier: B278TB2202E01M0
• UDI-Public: B278TB2202E01M0
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 01/09/2026

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: P231175-019
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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: TIBIAL BASEPLATE.; TIBIAL POLY SPACER.; TIBIAL ROTATIONAL HINGE.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Female