MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; FEMORAL HEAD

Lot Number 1887765

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Event Date 02/02/2024

Event Type  Injury  

Event Description

It was reported by (b)(6), an onkos distributor, that a 55-year-old female patient underwent a revision surgery to address an alleged infection.The surgery took place on (b)(6) 2024 and is the second revision surgery for this patient in which eleos devices were revised.At the time of this revision surgery, the then 55-year-old female patient with an eleos total femur replacement had nine (9) eleos components explanted and replaced except for the femoral head which was replaced with a non-onkos device.

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 alleged infection was not related to the design, manufacture, and/or sterilization of previously implanted eleos implants.The following mdrs are related to this adverse event: 3013450937-2024-00073, 3013450937-2024-00074, 3013450937-2024-00075, 3013450937-2024-00076, 3013450937-2024-00077, 3013450937-2024-00078, 3013450937-2024-00079, and 3013450937-2024-00080.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Type of Device: FEMORAL HEAD
• 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
• MDR Report Key: 18989361
• MDR Text Key: 338739086
• Report Number: 3013450937-2024-00081
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27826000026E0
• UDI-Public: B27826000026E0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 1887765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 140MM MALE-FEMALE MIDSECTION; 16MM TIBIAL POLY SPACER; 36MM +0MM TAPER FEMORAL HEAD; 40MM MALE-FEMALE MIDSECTION; 70MM MALE-MALE MIDSECTION; DISTAL FEMUR; DISTAL FEMUR AXIAL PIN; PROXIMAL FEMUR; TIBIAL ROTATIONAL HINGE
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female