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

Model Number KSP15140E

Device Problems Positioning Problem (3009); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/23/2021

Event Type  Injury  

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 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
• Type of Device: STEM EXTENSION, CANAL FILLING, 16X140MM, STRAIGHT, SPLINED, SLOTTED
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: jonathan zachok ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 11716326
• MDR Text Key: 247017868
• Report Number: 3013450937-2021-00056
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278KSP15140E0
• UDI-Public: B278KSP15140E0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2005
• Device Model Number: KSP15140E
• Device Catalogue Number: KSP15140E
• Device Lot Number: 1711956
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention