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

Model Number	25002201E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for one of four devices involved in this event, please refer to reports: 3013450937-2020-00054, 3013450937-2020-00055, and 3013450937-2020-00057.The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The sales representative spoke to the surgeon and his pa and they indicated that there was no problem with the components, but that this was a poor bone quality issue.A revision surgery has not been scheduled yet.Should additional information be obtained the report will be supplemented.
Event or Problem Description
Patient reported that their femur, tibia, and fibula fractured.

• Brand Name: ELEOS TIBIAL BASEPLATE
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany, nj
• MDR Report Key: 10009604
• Report Number: 3013450937-2020-00056
• Device Sequence Number: 16724548
• Product Code: KRO
• UDI-Device Identifier: B27825002201E0
• UDI-Public: B27825002201E0
• Combination Product (Y/N): N
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2020

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: 10/27/2025
• Device Model Number: 25002201E
• Device Catalogue Number: 25002201E
• Device Lot Number: 1721286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR