MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; MALE-FEMALE MIDSECTION

Lot Number	1935698
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	02/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All inspection and manufacturing data was reviewed for the device lots listed in the table above; the lots were found to be conforming to specifications and no manufacturing abnormalities were observed.As detailed in section 3.5, the ifu and surgical technique documentation identifies elements such as patient contraindications, patient selection factors, surgical procedures/techniques and other precautions/conditions that may contribute to adverse effects.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: 3013450937-2024-00035 3013450937-2024-00036 3013450937-2024-00037 3013450937-2024-00038 3013450937-2024-00039.
Event or Problem Description
It was reported by t.Stamper, an onkos sales representative, that a 62-year-old female patient with an eleos distal femur replacement underwent a revision surgery due to an alleged infection on (b)(6) 2024.The surgeon suspected an infection because the surgical wound never fully healed.The primary surgery took place on (b)(6) 2023.The patient was reportedly an oncology patient.All eleos explanted implants were replaced with new implants during the washout revision surgery.These devices were not returned for evaluation.All other eleos devices implanted during the primary surgery remain implanted in the patient.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: MALE-FEMALE MIDSECTION
• 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: 18818119
• Report Number: 3013450937-2024-00038
• Device Sequence Number: 19961378
• Product Code: KRO
• UDI-Device Identifier: B27825001050E0
• UDI-Public: B27825001050E0
• 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): 03/01/2024

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: 1935698
• 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: 02/20/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• 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; DISTAL FEMUR AXIAL PIN; MALE-FEMALE MIDSECTION; TIBIAL HINGE; TIBIAL POLY SPACER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female