MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; TAPER DISASSEMBLY TOOL

Lot Number	1488837
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
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 reported adverse event was not related to the design, manufacture, and/or sterilization of the subject devices.
Event or Problem Description
It was reported by (b)(4), an onkos distributor, that a 69-year-old female patient with an eleos total femur replacement (tfr) underwent revision due to the construct being too long; the presence of clinical symptoms is unknown.During the revision surgery, the taper disassembly tool reportedly became stuck during use.The surgeon subsequently disengaged the tfr construct from the dual mobility head and inserted a cement spacer.There was no alleged failure of the explanted implants to perform as intended; however, a follow-up surgery to replace the patient's tfr construct will be necessary.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: TAPER DISASSEMBLY TOOL
• 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: 21340557
• Report Number: 3013450937-2025-00011
• Device Sequence Number: 11724865
• Product Code: KRO
• UDI-Device Identifier: B27825107000EE0
• UDI-Public: B27825107000EE0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/08/2025

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: 1488837
• 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: 01/09/2025
• Initial Report FDA Received Date: 02/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2017
• 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: 69 YR
• Patient Sex: Female