MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS RESURFACING FEMUR AXIAL PIN; PROSTHESIS, KNEE

Model Number	25002114E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for one of three devices involved in the event, please refer to report 3013450937-2018-00071 and 3013450937-2018-00073 for the others.The device history records and sterilization batch release records were reviewed and indicated that all components involved met specification.The patient's operation notes and doctor's visit notes were reviewed, which revealed that the patient has a history of chronic infection associated with their total knee arthroplasty.It was determined that the adverse event was not related to the manufacture of the implants or a non-conformance.Should additional information be obtained the report will be supplemented.
Event or Problem Description
Patient visited their infectious disease doctor who confirmed the patient had an infection.Their doctor recommended an incision and drainage revision hinge total knee arthroplasty given the patient's chronic history of infections.A revision surgery was performed on (b)(6) 2018, to revise the eleos components and debride and irrigate the joint.

• Brand Name: ELEOS RESURFACING FEMUR AXIAL PIN
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 8069369
• Report Number: 3013450937-2018-00072
• Device Sequence Number: 11313398
• Product Code: KRO
• UDI-Device Identifier: B27825002114E0
• UDI-Public: B27825002114E0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2026
• Device Model Number: 25002114E
• Device Catalogue Number: 25002114E
• Device Lot Number: 1745415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR