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

Model Number	KSC12100E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3013450937-2022-00272
• Device Sequence Number: 5867879
• Product Code: KRO
• UDI-Device Identifier: B278KSC12100E0
• UDI-Public: B278KSC12100E0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male