MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS HINGE KNEE REPLACEMENT SYSTEM; RESURFACING PATELLA

Lot Number 1697851

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Subluxation (4525)

Event Date 12/11/2023

Event Type  Injury  

Event 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.

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 hartman, 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: 3013450937-2024-00002.

• Brand Name: ELEOS HINGE KNEE REPLACEMENT SYSTEM
• Type of Device: RESURFACING PATELLA
• 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: 18825675
• MDR Text Key: 336767862
• Report Number: 3013450937-2024-00049
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: B278KPONTP32E0
• UDI-Public: B278KPONTP32E0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2024

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: 1697851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RESURFACING PATELLA 32MM ALL-POLY, TRI-PEG; TIBIAL POLY SPACER 16MM
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male