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

Lot Number 1785592

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Damage to Ligament(s) (1952); Subluxation (4525)

Event Date 12/11/2023

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 332262074
• Report Number: 3013450937-2024-00002
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: B27825001216E0
• UDI-Public: B27825001216E0
• 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,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Lot Number: 1785592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates 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: ELEOS TIBIAL POLY SPACER - 25001216E; RESURFACING PATELLA 32MM ALL-POLY, TRI-PEG; TIBIAL POLY SPACER 16MM
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male