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

Model Number	KSC01465E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for one of two devices involved in this event, please refer to report: 3013450937-2020-00074.The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The patient has not undergone any surgical intervention at the time of this report.Should additional information be obtained the report will be supplemented.
Event or Problem Description
Patient x-rays revealed that the tibial baseplate and stem extension dissociated.

• Brand Name: ELEOS STEM EXTENSION
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany, nj
• MDR Report Key: 10059247
• Report Number: 3013450937-2020-00073
• Device Sequence Number: 2848661
• Product Code: KRO
• UDI-Device Identifier: B278KSC01465E0
• UDI-Public: B278KSC01465E0
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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: 04/18/2026
• Device Model Number: KSC01465E
• Device Catalogue Number: KSC01465E
• Device Lot Number: 1751336
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 05/14/2020
• 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