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

Lot Number	1717692
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	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with an alleged infection reportedly had all hardware removed and the operative leg amputated on (b)(6) 2024.
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 distributor, that a 34-year-old male patient with an eleos distal femur replacement and custom proximal tibia underwent a revision surgery on (b)(6) 2024 to remove all implanted hardware and perform an above the knee amputation the operative leg due to a chronic infection.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: SEGMENTAL STEM
• 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: 19378099
• Report Number: 3013450937-2024-00173
• Device Sequence Number: 15330914
• Product Code: KRO
• UDI-Device Identifier: B278SPSE0005E0
• UDI-Public: B278SPSE0005E0
• 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: 2019
• 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): 07/12/2024

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: 01/30/2026
• Device Lot Number: 1717692
• 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: 05/09/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2018
• 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: CANAL FILLING SEGMENTAL STEM; CANAL FILLING SEGMENTAL STEM; CEMENTED COLLAR STEM; CEMENTED COLLAR STEM; COLLAR LOCKING RING; COLLAR LOCKING RING; CUSTOM PROXIMAL TIBIAL DEVICE; CUSTOM PROXIMAL TIBIAL DEVICE; DISTAL FEMUR AXIAL PIN; DISTAL FEMUR AXIAL PIN; DISTAL FEMUR LEFT; DISTAL FEMUR LEFT; POROUS BIOGRIP COLLAR; POROUS BIOGRIP COLLAR; TIBIAL POLY SPACER; TIBIAL POLY SPACER; TIBIAL ROTATIONAL HINGE; TIBIAL ROTATIONAL HINGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male