MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TIBIAL HINGE COMPONENT; PROSTHESIS, KNEE

Model Number 25002100E

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The explanted component was unable to be returned for further analysis.Should additional information be obtained the report will be supplemented.

Event Description

The patient's knee was unable to be reduced, during a surgery, and in the process the poly on the bushings of the tibial hinge component became deformed and the implant needed to be replaced.

• Brand Name: ELEOS TIBIAL HINGE COMPONENT
• 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: 9582269
• MDR Text Key: 186381860
• Report Number: 3013450937-2020-00003
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825002100E0
• UDI-Public: B27825002100E0
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25002100E
• Device Catalogue Number: 25002100E
• Device Lot Number: 1820256
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2019
• 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: 54 YR