MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; STEM EXTENSION

Lot Number	1697272
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of this complaint was not determined.The reported information indicates that the construct was not properly assembled as detailed in the ifu and surgical technique.
Event or Problem Description
It was reported by (b)(6), an onkos sales representative, that a 57-year-old male patient with an eleos hinge knee replacement and eleos proximal tibial replacement underwent revision surgery on (b)(6) 2024 after the patient fell which caused a disassociation of the stem extension fom the refurfacing femur.
Event or Problem Description
It was reported by (b)(6), an onkos sales representative, that a 57-year-old male patient with an eleos hinge knee replacement and eleos proximal tibial replacement underwent revision surgery on (b)(6) 2024 after the patient fell which caused a disassociation of the stem extension fom the refurfacing femur.
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 for the reported dissociation of the stem extension from the resurfacing femur was not related to the design, manufacture, and/or sterilization of the explanted devices.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: STEM EXTENSION
• 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: 20306091
• Report Number: 3013450937-2024-00304
• Device Sequence Number: 7791628
• Product Code: KRO
• UDI-Device Identifier: B278KSC12100E0
• UDI-Public: B278KSC12100E0
• 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,Followup
• Report Date (Section B): 09/25/2024

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 Expiration Date: 03/21/2025
• Device Lot Number: 1697272
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2017
• 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: 57 YR
• Patient Sex: Male