MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; PROXIMAL FEMUR

Lot Number	P220811-002
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	02/02/2024
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 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: 3013450937-2024-00074, 3013450937-2024-00075, 3013450937-2024-00076, 3013450937-2024-00077, 3013450937-2024-00078, 3013450937-2024-00079, 3013450937-2024-00080, 3013450937-2024-00081.
Event or Problem Description
It was reported by (b)(4), 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.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: PROXIMAL FEMUR
• 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: 18989336
• Report Number: 3013450937-2024-00073
• Device Sequence Number: 12857393
• Product Code: KRO
• UDI-Device Identifier: B278PF2000L02M0
• UDI-Public: B278PF2000L02M0
• 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): 03/27/2024

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: P220811-002
• 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: 03/20/2024
• Initial Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2023
• 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: 140MM MALE-FEMALE MIDSECTION.; 16MM TIBIAL POLY SPACER.; 36MM +0MM TAPER FEMORAL HEAD.; 40MM MALE-FEMALE MIDSECTION.; 70MM MALE-MALE MIDSECTION.; DISTAL FEMUR AXIAL PIN.; DISTAL FEMUR.; PROXIMAL FEMUR.; TIBIAL ROTATIONAL HINGE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female