MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; ROTATIONAL HINGE

Lot Number	1800150
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	01/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by will mcdonald, an onkos distributor, that a 32-year-old female patient with an eleos distal femur replacement underwent a revision surgery due to an alleged joint infection on (b)(4) 2024.The primary surgery took place on (b)(4) 2019 when the patient was 28 years old.The explanted devices were not returned for evaluation and identifying lot numbers were not provided for several of the explanted devices.Numerous attempts to obtain additional information from will mcdonald were made via phone and email; no additional information was provided.All other eleos devices implanted during the primary surgery remain implanted in the patient.
Additional Manufacturer Narrative
It was reported by will mcdonald, an onkos distributor, that a 32-year-old female patient with an eleos distal femur replacement underwent a revision surgery due to an alleged joint infection on (b)(4) 2024.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.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: ROTATIONAL HINGE
• 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: 18817880
• Report Number: 3013450937-2024-00052
• Device Sequence Number: 4342891
• Product Code: KRO
• UDI-Device Identifier: B27825002100E0
• UDI-Public: B27825002100E0
• 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): Unknown
• 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: 1800150
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2019
• 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: 32 YR
• Patient Sex: Female