MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; DISTAL FEMUR AXIAL PIN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

The root cause for the revision surgery and amputation was determined to be prior trauma that the patient sustained.The sales representative stated that there was no failure of the eleos components.However, the sales representative has not been able to provide information on the explanted components, therefore, the dhrs have not been reviewed.Once more information is known, a supplemental report will be submitted once more information is available.

Event Description

A patient underwent a revision surgery to remove eleos components on (b)(6) 2021 performed by doctor (b)(6).The components were removed in preparation for the patient's limb to be amputated.The patient sustained a fall approximately nine months prior to this revision surgery and was treated by an unknown hospital for a periprosthetic bone fracture distal to the patient's proximal tibia implant.The sales representative reported that cortical screws were placed to the repair the periprosthetic fracture.The sales representative stated that the patient was noncompliant with post-operative instructions after the surgery.The patient sustained a subsequent fall two weeks prior to this revision surgery which caused a sagittal fracture of the patient's tibia.The patient's physician determined that amputation would be the best course of treatment for the patient.It was reported that there was no failure of the implants and they did not contribute to the falls the patient sustained or the amputation.A distal femur implant, tibial hinge component, tibial poly spacer, a femoral segmental stem, a tibial baseplate, a distal femur axial pin, and a tibial stem extension were explanted.It is currently unknown when these implants were placed originally.

Manufacturer Narrative

The complainant was unable to determine lot information for components explanted as part of this event.Therefore, dhrs were unable to be reviewed.There is still no evidence that the components contributed to the failure.

• Brand Name: ELEOS
• Type of Device: DISTAL FEMUR AXIAL PIN
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11826300
• MDR Text Key: 262231436
• Report Number: 3013450937-2021-00076
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention