MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TIBIAL POLY SPACER; PROSTHESIS, KNEE

Model Number 25001208E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Joint Swelling (2356)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

This report is for one of three devices involved in this event, please refer to report 3013450937-2019-00065 and 3013450937-2019-00067.The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The component was unable to be obtained for further analysis.Should additional information be obtained the report will be supplemented.

Event Description

The patient underwent a revision surgery due to an alleged infection.

• Brand Name: ELEOS TIBIAL POLY SPACER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDIC; 5677 airline road; arlington TN 38002
• Manufacturer Contact: cristina butrico ; 77 east halsey road; parsippany, NJ 07054 ; 9732645433
• MDR Report Key: 9356253
• MDR Text Key: 168018038
• Report Number: 3013450937-2019-00066
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825001208E0
• UDI-Public: B27825001208E0
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25001208E
• Device Catalogue Number: 25001208E
• Device Lot Number: 1751055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• 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): Required Intervention
• Patient Age: 62 YR