MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL HINGE COMPONENT, W/ ROTATIONAL STOP

Model Number 25002100E

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The fractured component was requested for further evaluation.Should additional information be obtained the report will be supplemented.

Event Description

Patient underwent a revision surgery due to the post of the tibial hinge component fracturing.

Event Description

Patient underwent a revision surgery due to the post of the tibial hinge component fracturing.

Manufacturer Narrative

This mdr si being submitted as a correction to the previous submission as well as an update of the findings after further investigation into this failure.The previous mdr was submitted with the incorrect lot number of the device as it was mistakenly believed that the failed tibial hinge component was placed on (b)(6) 2020.This component, with the lot number 1825933, was actually explanted on (b)(6) 2020 when the patient underwent a subsequent revision surgery due to an alleged infection.An antibiotic spacer was placed during the surgery.The patient underwent another revision surgery on (b)(6) 2020 to remove the antibiotic spacer and place new eleos components.The tibial hinge component that was placed on (b)(6) 2020 with the lot number 1793804 was the component that fractured and led to the revision surgery that occured on 03 november 2020 which was investigated in this complaint.The mdr submission has been corrected in this report.A capa was also opened to further investigate the root cause of this failure as well as other fractures of tibial hinge components.The capa root cause analysis found that a likely cause of the failure was the patient's high activity level.The capa also found that the device was not a likely root cause of the failure as it was manufactured to the correct specification and was able to perform its intended use.The patient is an avid hiker and continued to perform strenuous activity despite warnings from device labelling and his health care providers.A custom tibial hinge component with increased strength compared to the standard products available was manufactured in an attempt to mitigate further fractures.The previous implants were not made available for testing as the patient retained them after they were explanted.

• Brand Name: ELEOS
• Type of Device: TIBIAL HINGE COMPONENT, W/ ROTATIONAL STOP
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 10936053
• MDR Text Key: 219326700
• Report Number: 3013450937-2020-00180
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825002100E0
• UDI-Public: B27825002100E0
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25002100E
• Device Catalogue Number: 25002100E
• Device Lot Number: 1793804
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR