MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS SEGMENTAL STEM; PROSTHESIS, KNEE

Model Number	25004013E
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for one of six devices involved in this event, please refer to report 3013450937-2020-00067, 3013450937-2020-00068, 3013450937-2020-00069, 3013450937-2020-00070, and 3013450937-2020-00071.The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The patient had a confirmed infection, during their previous surgery.The component was unable to be obtained for further analysis.Should additional information be obtained the report will be supplemented.
Event or Problem Description
The patient underwent the second part of their revision surgery were a full revision was performed due to the patient's previous infection.Upon intraoperative inspection it was identified that the femoral stem had loosened from the bone.

• Brand Name: ELEOS SEGMENTAL STEM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany, nj
• MDR Report Key: 10040323
• Report Number: 3013450937-2020-00066
• Device Sequence Number: 2812728
• Product Code: KRO
• UDI-Device Identifier: B27825004013E0
• UDI-Public: B27825004013E0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2020

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: 03/11/2025
• Device Model Number: 25004013E
• Device Catalogue Number: 25004013E
• Device Lot Number: 1699501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 05/08/2020
• 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: 45 YR