MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STEM EXTENSION, CANAL FILLING, 16X140MM, STRAIGHT, SPLINED, SLOTTED

Model Number	KSP15140E
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the problem implanting the stem extension was unable to be determined.The sales representative has not provided information on the issue.If more information is provided, a supplement report will be submitted.However, based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or the sterilization of the implants or a nonconformance.
Event or Problem Description
An unknown patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6).Due to hip instability.During surgery, the surgeon attempted to place a stem extension in the patient's tibia.The stem extension was unable to be placed.It is not known why the stem extensions was not able to be placed.

• Brand Name: ELEOS
• Common Device Name: STEM EXTENSION, CANAL FILLING, 16X140MM, STRAIGHT, SPLINED, SLOTTED
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11716326
• Report Number: 3013450937-2021-00056
• Device Sequence Number: 19730862
• Product Code: KRO
• UDI-Device Identifier: B278KSP15140E0
• UDI-Public: B278KSP15140E0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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: 06/20/2005
• Device Model Number: KSP15140E
• Device Catalogue Number: KSP15140E
• Device Lot Number: 1711956
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/23/2021
• 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