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

Lot Number	1785592
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Subluxation (4525)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation in progress, additional information for this event is not known at this time, if additional information is received, a supplemental report will be submitted accordingly.
Event or Problem Description
It was an onkos resurfacing hinge originally implanted.The patients patella started subluxing.Surgeons performed a petellaectomy and extensor mechanism and did fresh poly exchange while at it.
Additional Manufacturer Narrative
It was reported by (b)(4), an onkos sales representative, that a 65-year-old male patient with an eleos hine knee replacement underwent a revision surgery due to subluxation of the patient's anatomical patella on (b)(6) 2023.The surgeon, doctor (b)(6), performed a patellectomy to remove the patient's anatomical patella which included an attached eleos resurfacing patella.The eleos 16mm poly spacer was swapped for a new one at the time.All inspection and manufacturing data was reviewed for the revised eleos implants; all reviewed information was 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 potentially 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 reported patellar subluxation was not related to the design, manufacture, and/or sterilization of the previously implanted eleos device.The following mdrs are related to this adverse event: 3013450937-2024-00049 (added per investigation).
Event or Problem Description
It was reported by (b)(4), an onkos sales representative, that a 65-year-old male patient with an eleos hine knee replacement underwent a revision surgery due to subluxation of the patient's anatomical patella on (b)(6) 2023.The surgeon, doctor (b)(6), performed a patellectomy to remove the patient's anatomical patella which included an attached eleos resurfacing patella.The eleos 16mm poly spacer was swapped for a new one at the time.The then 63-year-old patient had previously been implanted with the eleos hinge knee replacement on (b)(6) 2022.No additional patient information was provided.

• Brand Name: ELEOS HINGE KNEE REPLACEMENT SYSTEM
• Common Device Name: TIBIAL POLY SPACER
• 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: 18452007
• Report Number: 3013450937-2024-00002
• Device Sequence Number: 15361666
• Product Code: JWH
• UDI-Device Identifier: B27825001216E0
• UDI-Public: B27825001216E0
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 03/04/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Lot Number: 1785592
• 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: 12/05/2023
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2017
• 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: ELEOS TIBIAL POLY SPACER - 25001216E; RESURFACING PATELLA 32MM ALL-POLY, TRI-PEG; TIBIAL POLY SPACER 16MM
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male