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

Model Number KSP14100E

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2023

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 310676775
• Report Number: 3013450937-2023-00039
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278KSP14100E0
• UDI-Public: B278KSP14100E0
• 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: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2017
• 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
• Patient Outcome(s): Required Intervention