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

Model Number KSC12100E

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

Patient Problem Unspecified Infection (1930)

Event Date 06/27/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent revision surgery for a poly swap of eleos implants.It is likely that the patient's implanted eleos distal femur axial pin, eleos tibial hinge component, and eleos polyspacer were removed and replaced.On 23 september 2022, additional information was received regarding this event: it was reported that the patient developed an alleged infection and underwent a revision surgery on (b)(6) 2022.During the revision surgery, the surgeon revised the tibial hinge component, distal femur axial pin, and tibial poly spacer.The following eleos implants remain implanted from the patient's surgery on (b)(6) 2022: distal femur, male-female midsection, cemented segmental stem, canal-filling segmental stem, tibial baseplate, two tibial block augments, and a cemented stem extension.All parts implanted at the time of infection will be reported.This event will be reported to the fda as a serious injury due to the revision.This record captures the eleos cemented stem extension.

Manufacturer Narrative

It was reported that the patient developed an alleged infection and underwent a revision surgery on (b)(6) 2022.During the revision surgery, the surgeon revised the tibial hinge component, distal femur axial pin, and tibial poly spacer.The following eleos implants remain implanted from the patient's surgery on (b)(6) 2022: distal femur, male-female midsection, cemented segmental stem, canal-filling segmental stem, tibial baseplate, two tibial block augments, and a cemented stem extension.A review of the work orders and sterilization batch release records for the products involved found no indication that the alleged infection was a result of a manufacturing or sterilization nonconformance.The root cause identified for this complaint is an alleged infection, which required surgical intervention.The root cause of the patient's alleged infection could not be determined.Ultimately, based upon the device history records, sterilization records, and interview with the regional sales manager the investigation concluded that the root cause of the alleged infection is not related to the design, manufacture, and/or sterilization of the components.

• Brand Name: ELEOS
• Type of Device: CEMENTED STEM EXTENSION
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd
• MDR Report Key: 15656627
• MDR Text Key: 302251043
• Report Number: 3013450937-2022-00272
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278KSC12100E0
• UDI-Public: B278KSC12100E0
• 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
• Report Date: 10/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KSC12100E
• Device Catalogue Number: KSC12100E
• Device Lot Number: 1880783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2021
• 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
• Patient Age: 44 YR
• Patient Sex: Male