MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STEM EXTENSION, CANAL-FILLING, 14X140MM, STRAIGHT

Model Number KSP13140E

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Ulcer (2274)

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

The root cause for the patient developing ulcers around the eleos implants was unable to be definitively determined.It was not reported that the surgeon believed that there was a malfunction of the implants.No information is known about the patient's medical history, and it is unknown if it may have contributed to this complaint.There were no indications that there was a nonconformance during manufacturing or sterilization which would have contributed to the complaint.

Event Description

A patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6).The surgery was performed due to ulceration around eleos total femur component.During the surgery, the surgeon removed all implants that were implanted at the time as it was decided that the patient's leg would be amputated above the knee.To give the patient's thigh structure, a male-female midsection with a custom end cap implant was placed in the patient's upper leg.

• Brand Name: ELEOS
• Type of Device: STEM EXTENSION, CANAL-FILLING, 14X140MM, STRAIGHT
• 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: 12441355
• MDR Text Key: 270370376
• Report Number: 3013450937-2021-00185
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278KSP13140E0
• UDI-Public: B278KSP13140E0
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KSP13140E
• Device Catalogue Number: KSP13140E
• Device Lot Number: 1735025
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2018
• 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
• Treatment: 25000001E- ELEOS PROXIMAL FEMUR; 25000007E- ELEOS DISTAL FEMUR; 25000071E- ELEOS MALE-MALE MIDSECTION; 25001090E- ELEOS MALE-FEMALE MIDSECTION, 90MM; 25001140E- ELEOS MALE-FEMALE MIDSECTION 140MM; 25001208E- ELEOS TIBIAL POLY SPACER; 25002101E- ELEOS TIBIAL HINGE COMPONENT; 25002111E- ELEOS DISTAL FEMUR AXIAL PIN; 25002203E- ELEOS TIBIAL BASEAPLATE
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR