MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS HINGE KNEE REPLACEMENT; TIBIAL POLY SPACER

Lot Number	1856902
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is a retrospective investigation regarding two of the three revision surgeries for a single patient that onkos was previously unaware.Refer to section 3.0 for additional information.During the first revision surgery on (b)(6) 2022, the originally implanted 8mm tibial poly spacer was replaced with a 12mm tibial poly spacer.During the second revision surgery on (b)(6) 2023, the 12mm tibial poly spacer was replaced with a 20mm tibial poly spacer.The patient received an eleos hinge knee replacement on (b)(6) 2022 at which time an 8mm tibial poly spacer was implanted.The surgeon for the primary surgery and the first two surgical revisions was performed by doctor siverhus.The third revision was performed by (b)(6).Additional patient history and surgical details were not able to be provided upon request to (b)(6).
Additional Manufacturer Narrative
This report is a retrospective investigation regarding two of the three revision surgeries for a single patient that onkos was previously unaware.During the first revision surgery on (b)(6) 2022, the originally implanted 8mm tibial poly spacer was replaced with a 12mm tibial poly spacer.During the second revision surgery on (b)(6) 2023, the 12mm tibial poly spacer was replaced with a 20mm tibial poly spacer.All inspection and manufacturing data was reviewed for the known revised eleos implants; 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 represent potential contributing factors to the adverse effect(s) identified in this complaint.The root cause of the historical adverse events associated with this retrospective complaint were not determined; however, the reported patient weight including excessive soft tissue surrounding the knee joint is likely to be significant contributing factor.Based on review of device history records, the investigation concluded that the root cause of the knee joint laxity and/or dislocation was not related to the design, manufacture, and/or sterilization of the known revised eleos implants.The following mdrs were submitted as part of this adverse event: 3013450937-2024-00050 (retrospective investigation; revision surgery #2) 3013450937-2024-00056( retrospective investigation, revision surgery #1).

• Brand Name: ELEOS HINGE KNEE REPLACEMENT
• Common Device Name: TIBIAL POLY SPACER
• 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: 18845570
• Report Number: 3013450937-2024-00050
• Device Sequence Number: 18226003
• 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: 2022
• Device Explanted Year: 2023
• 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): 03/06/2024

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: 1856902
• 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: 12/05/2023
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2020
• 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: 12MM POLY SPACER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male