MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS RESURFACING FEMUR, SIZE 2, RIGHT

Model Number 2500R002E

Device Problem Break (1069)

Patient Problem Joint Laxity (4526)

Event Date 12/16/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is in process. The device is expected to be returned for evaluation. When the investigation is complete, a supplemental mdr will be submitted accordingly. Multiple mdr reports were submitted for this event: #3013450937-2022-00002.

Event Description

It was reported that the patient underwent a revision surgery on (b)(6) 2021. The patient presented with varus/valgus instability. During the revision surgery, it was observed that the stem extension dissociated from the resurfacing femur. It was observed that the boss of the resurfacing femur was cracked. The surgeon debrided the wound and explanted the following implants: poly spacer, resurfacing femur, tibial hinge component, resurfacing femur axial pin, and stem extension. The surgeon placed a distal femoral replacement system. No additional information regarding this adverse event has been reported.

• Brand Name: ELEOS
• Type of Device: RESURFACING FEMUR, SIZE 2, RIGHT
• 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: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 13168650
• MDR Text Key: 283254049
• Report Number: 3013450937-2022-00001
• Device Sequence Number: 1
• Product Code: KRO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 2500R002E
• Device Catalogue Number: 2500R002E
• Device Lot Number: 1731796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/05/2022 Patient Sequence Number: 1

Treatment

P/N 25001220E, ELEOS TIBIAL POLY SPACER; P/N 25002100E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002112E, ELEOS RESURFACING FEMUR AXIAL PIN; P/N KSP10140E, ELEOS CANAL-FILLING STEM EXTENSION