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

Lot Number	1954163
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of this complaint was not determined.Based on the review of device history records, the investigation concluded that the root cause of the unknown incident was not related to the design, manufacture, and/or sterilization of the revised devices.
Event or Problem Description
A historical adverse event was discovered during the investigation of (b)(4), wherein a 68-year-old male patient with an eleos distal femur replacement underwent revision surgery on (b)(6) 2024 for an unknown reason.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: TIBIAL ROTATIONAL HINGE
• 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: 21029224
• Report Number: 3013450937-2024-00418
• Device Sequence Number: 4071034
• Product Code: KRO
• UDI-Device Identifier: B278THSMWOS01M0
• UDI-Public: B278THSMWOS01M0
• 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: 2023
• 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): 12/27/2024

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: 1954163
• 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: 12/23/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2022
• 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: DISTAL FEMUR AXIAL PIN; TIBIAL POLY SPACER; TIBIAL ROTATIONAL HINGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male