MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED STRAIGHT STEM EXTENSION, 15X30MM

Model Number	KSC01530E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2023-00149, #3013450937-2023-00150, #3013450937-2023-00151, #3013450937-2023-00152, #3013450937-2023-00153, #3013450937-2023-00155, #3013450937-2023-00156, #3013450937-2023-00157, #3013450937-2023-00158.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to an alleged infection.During the revision surgery, the following eleos implants were revised: tibial hinge component, distal femur axial pin, and poly spacer.The following eleos implants remain implanted from the patient's original procedure: distal femur, male-female midsection, stem extension, resurfacing patella, tibial baseplate, cemented bowed segmental stem, and tibial baseplate tapered screw.The surgeon performed a washout.No additional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
It was reported that the patient developed an alleged infection.The patient underwent a revision surgery on (b)(6) 2023 where the following eleos implants were revised: tibial hinge w/ rotational stop, distal femur axial pin, and tibial poly spacer.The following eleos implants remain implanted from the patient's original surgery: distal femur, cemented segmental stem, tibial baseplate tapered screw, stem extension, male-female midsection, tibial baseplate, and resurfacing patella.The work orders and sterilization batch release records were revewied and no relevant information was identified.The root cause of the patient's alleged infection could not be determined.The investigation concluded that the root cause of the alleged infection is not likely due to the design, manufacture, and/or sterilization of the components.The following sections were updated: b4 - updated date of this report.G1 - changed submitter information - name and email.G3 - updated date received by manufacturer.G6 - updated type of report.H6 - updated codes to reflect investigation results.H10 - updated mfg narrative to reflect investigation results.

• Brand Name: ELEOS
• Common Device Name: CEMENTED STRAIGHT STEM EXTENSION, 15X30MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline rd; arlington TN 38002
• Manufacturer Contact: vandita patel ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17560957
• Report Number: 3013450937-2023-00154
• Device Sequence Number: 3640333
• Product Code: KRO
• UDI-Device Identifier: B278KSC01530E0
• UDI-Public: B278KSC01530E0
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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 Expiration Date: 04/28/2025
• Device Model Number: KSC01530E
• Device Catalogue Number: KSC01530E
• Device Lot Number: 1704388
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25000009E, ELEOS DISTAL FEMUR; P/N 25001040E, ELEOS MALE FEMALE MIDSECTION; P/N 25001212E, ELEOS POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N CB-15152-03M, ELEOS SEGMENTAL STEM; P/N KPONTP35E, ELEOS RESURFACING PATELLA; P/N TB-2204E-01M, ELEOS TIBIAL BASEPLATE; P/N TB-TSCRW-01M, ELEOS TIBIAL BASEPLATE SCREW; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female