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

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.

Event Description

It was reported that the patient's canal-filling segmental stem loosened.The patient underwent a revision surgery on (b)(6) 2022 where the canal-filling segmental stem was revised to a cemented segmental stem.During the revision surgery, the following eleos implants were also revised: tibial hinge component, male-female midsection, tibial poly spacer, distal femur, and distal femur axial pin.Attempts have been made and no additional information regarding this adverse event has been obtained.

Event Description

It was reported that the patient's canal-filling stem extension loosened.The patient underwent a revision surgery on (b)(6) 2022 where their hinge knee replacement was revised to a distal femoral replacement.During the revision surgery, the following eleos implants were placed: cemented segmental stem, tibial hinge component, male-female midsection, tibial poly spacer, distal femur, and distal femur axial pin.Attempts have been made and no additional information regarding this adverse event has been obtained.

Manufacturer Narrative

This report is being submitted to include additional and corrected information.The investigation is complete.The device was not returned for evaluation.The root cause of the alleged loosening could not be determined.Multiple attempts were made to obtain additional information.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added.G3: date received by manufacturer added.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4114: device not returned.H6: type of investigation code updated to 4117: device not accessible for testing.H6: type of investigation code updated to 4109: historical data analysis.H6: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.

• Brand Name: ELEOS
• Type of Device: CANAL-FILLING STEM EXTENSION
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 15591544
• MDR Text Key: 301636303
• Report Number: 3013450937-2022-00300
• Device Sequence Number: 1
• Product Code: KRO
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization