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

Model Number 25002111E

Device Problem Insufficient Information (3190)

Patient Problem Inflammation (1932)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

The root cause of the failure was unable to be definitively determined.Device history records and sterilization batch release records were reviewed and no issues during manufacturing or sterilization were identified that would indicate that the manufacturing or sterilization of the involved implants contributed to this complaint.

Event Description

A patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) to replace poly components that were placed during a previous surgery which occurred on (b)(6)2019.The previous surgery was a non-eleos revision.During the revision surgery, the surgeon replaced a tibial poly spacer, a distal femur axial pin, and a tibial hinge component.

• Brand Name: ELEOS
• Type of Device: DISTAL FEMUR AXIAL PIN, ONE SIZE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: jonathan zachok ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 11497392
• MDR Text Key: 240138515
• Report Number: 3013450937-2021-00024
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825002111E0
• UDI-Public: B27825002111E0
• 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
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25002111E
• Device Catalogue Number: 25002111E
• Device Lot Number: 1807957
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR