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

Model Number KSC16100E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sudden Cardiac Death (2510)

Event Date 11/16/2017

Event Type  Death  

Manufacturer Narrative

This medical device report (mdr) was initiated as part of a retrospective assessment of complaints under onkos surgical capa (b)(4).As part of this assessment, onkos surgical re-evaluated all complaints received to ensure mdrs were filed when required.The results of this retrospective assessment prompted onkos surgical to file this report.This report is for one of eight devices involved in this event, please refer to report 3013450937-2018-00036, 3013450937-2018-00037, 3013450937-2018-00038, 3013450937-2018-00039, 3013450937-2018-00040, 3013450937-2018-00041, and 3013450937-2018-00042 for the others.The device history records and sterilization batch release records were reviewed and indicated that the components involved met specification.It was determined that the adverse event was not related to the manufacture of the implants or a non-conformance and this complaint has been closed.Should additional information be obtained, the complaint will be re-opened, and this report will be supplemented.

Event Description

Patient went into cardiac arrest, during a revision surgery, and was unable to be resuscitated.The revision surgery was performed to remove unknown components due to a comminuted supracondylar fracture on their distal femur and place an eleos distal femur limb salvage system.

• Brand Name: ELEOS STEM EXTENSION CEMENTED
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDIC; 5677 airline road; arlington TN 38002
• Manufacturer Contact: cristina butrico ; 77 east halsey road; parsippany, NJ 07054 ; 9732645433
• MDR Report Key: 7839725
• MDR Text Key: 119015100
• Report Number: 3013450937-2018-00043
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278KSC16100E0
• UDI-Public: B278KSC16100E0
• 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
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KSC16100E
• Device Catalogue Number: KSC16100E
• Device Lot Number: 1697274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2017
• 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): Death
• Patient Age: 78 YR