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	No Information (3190)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for one of five devices involved in this event, please refer to report 3013450937-2019-00069, 3013450937-2019-00070, 3013450937-2019-00072, and 3013450937-2019-00073.The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.Should additional information be obtained the report will be supplemented.
Event or Problem Description
Patient presented with appreciable medio-lateral instability.
Additional Manufacturer Narrative
This report is for one of five devices involved in this event, please refer to report 3013450937-2019-00069, 3013450937-2019-00070, 3013450937-2019-00072, and 3013450937-2020-00046.The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.This report is being supplemented because it was identified that the component was revised on (b)(6) 2020.The clinical director, present during the case, indicated that there was no apparent damage to the revised component, and it was unable to be obtained for further analysis.Should additional information be obtained the repot will be supplemented.
Event or Problem Description
Patient underwent a revision surgery due to the resurfacing femur loosening and the resurfacing femur and stem extension dissociating.

• Brand Name: ELEOS RESURFACING FEMUR AXIAL PIN
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany, nj NJ 07054
• MDR Report Key: 9497705
• Report Number: 3013450937-2019-00071
• Device Sequence Number: 1878126
• Product Code: KRO
• UDI-Device Identifier: B27825002114E0
• UDI-Public: B27825002114E0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 03/17/2025
• Device Model Number: 25002114E
• Device Catalogue Number: 25002114E
• Device Lot Number: 1701674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 03/26/2020
• 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: 21 YR