MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS DISTAL FEMUR REPLACEMENT; TIBIAL POLY SPACER 12MM

Lot Number	1813666
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Medical device site infection (4845)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Several attempts to obtain additional information have not yielding further details.A supplemental mdr will be submitted when details are received.
Event or Problem Description
It was reported by b.Matsen that an eleos dfr patient underwent a revision surgery.Additional details are not available at this time.
Event or Problem Description
It was reported by (b)(4), an onkos distributor, that a 76-year-old male patient with an eleos distal femur replacement underwent a revision surgery on (b)(6) 2024 due to an alleged joint infection.
Additional Manufacturer Narrative
It was reported by (b)(4), an onkos distributor, that a 76-year-old male patient with an eleos distal femur replacement underwent a revision surgery on (b)(6) 2024 due to an alleged joint infection.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 were submitted as part of this adverse event: 3013450937-2024-00057.3013450937-2024-00061 (added as reportable during investigation).3013450937-2024-00062 (added as reportable during investigation).

• Brand Name: ELEOS DISTAL FEMUR REPLACEMENT
• Common Device Name: TIBIAL POLY SPACER 12MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany 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: 18833005
• Report Number: 3013450937-2024-00057
• Device Sequence Number: 12616331
• Product Code: KRO
• UDI-Device Identifier: B27825001212E0
• UDI-Public: B27825001212E0
• 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,Followup
• Report Date (Section B): 03/07/2024

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: 1813666
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2019
• 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 AXIAL PIN; TIBIAL POLY SPACER 16MM; TIBIAL POLY SPACER 16MM; TIBIAL ROTATIONAL HINGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male