MAUDE Adverse Event Report: ONKOS SURGICAL, INC. ELEOS; STEM EXTENSION, CANAL-FILLING

Model Number	KSP14100E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation for this event is in progress.Once additional information is received, a supplemental report will be submitted accordingly.The mdrs associated with this event are: 013450937-2023-00038, 013450937-2023-00039.
Event or Problem Description
It was reported that a patient underwent revision surgery on 01 (b)(6) 2023, due to loosening of the patient's eleos resurfacing femur and eleos stem extension.The patient was revised to remove and replace those two components.The patient's revision surgery was completed successfully.This event will be reportable to the fda as a serious injury due to the patient's revision procedure.This record captures the eleos stem extension.
Additional Manufacturer Narrative
It was reported that the patient underwent a revision surgery on (b)(6) 2023 due to loosening of the patient's canal-filling stem extension and dissociation of the resurfacing femur and canal-filling stem extension.The following eleos implants were revised during the revision surgery: resurfacing femur axial pin, canal-filling stem extension, tibial hinge component, resurfacing femur, and tibial poly spacer.There were no alleged deficiencies with the tibial hinge component, resurfacing femur axial pin, and tibial poly spacer.Device production records and historical data was reviewed, and no abnormailities were identified.Visual, dimensional and functional analysis could not be conducted as the devices were not returned for evaluation.Additional information regarding the patient's post-operative compliance, external trauma, and surgeon's surgical technique are not known.Ultimately, the root cause for dissociation and loosening could not be determined.The mdrs associated with this event are: 013450937-2023-00038; 013450937-2023-00038-001; 013450937-2023-00039-001.

• Brand Name: ELEOS
• Common Device Name: STEM EXTENSION, CANAL-FILLING
• Manufacturer (Section D): ONKOS SURGICAL, INC.; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 16482049
• Report Number: 3013450937-2023-00039
• Device Sequence Number: 15397319
• Product Code: KRO
• UDI-Device Identifier: B278KSP14100E0
• UDI-Public: B278KSP14100E0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2025
• Device Model Number: KSP14100E
• Device Catalogue Number: KSP14100E
• Device Lot Number: 1711947
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown