MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS TIBIAL POLYSPACER

Model Number 25001210E

Device Problem Fracture (1260)

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

Event Date 03/30/2022

Event Type  Injury  

Event Description

It was reported that a patient was revised on (b)(6) 2022 due to a broken eleos poly spacer.The device was removed and replaced.No additional information is available at this time.Due to the revision surgery, this event will be reportable to the fda as a serious injury.The following implants were also revised during the procedure: eleos tibial hinge and eleos distal femur axial pin.No alleged issues occured with these devices; therefore, they are concomitant.

Manufacturer Narrative

The patient underwent a revision surgery on (b)(6) 2022 due to a broken eleos poly spacer.During the procedure, dr.(b)(6) removed and replaced the broken poly spacer, the tibial hinge component, and the distal femur axial pin.No issues were reported for the tibial hinge component and distal femur axial pin; therefore, these devices are concomitant.The patient was initially implanted with eleos devices on (b)(6) 2019; however, device specific details are unknown.A review of the work orders and sterilization batch release records could not be completed due to lack of productinformation.The root cause for this complaint could not be determined conclusively.As the device was implanted for approximately three years, it is possible that residual post-operative motion may have contributed to the alleged damage to the poly spacer.However, as the device was not available for evaluation, further investigation was not possible.If additional information becomes available, this record will be updated accordingly.

• Brand Name: ELEOS
• Type of Device: ELEOS TIBIAL POLYSPACER
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC; 5677 airline rd; arlington TN 38002
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 14246717
• MDR Text Key: 290375079
• Report Number: 3013450937-2022-00152
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825001210E0
• UDI-Public: B27825001210E0
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25001210E
• Device Catalogue Number: 25001210E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: No
• 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: DISTAL FEMUR AXIAL PIN.; TIBIAL HINGE COMPONENT.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female