MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED STEM EXTENSION, 12X100MM, STRAIGHT

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	08/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.The following mdrs were also submitted for this adverse event: 3013450937-2023-00192, 3013450937-2023-00193, 3013450937-2023-00194, 3013450937-2023-00195, 3013450937-2023-00197, 3013450937-2023-00198, 3013450937-2023-00199, 3013450937-2023-00200, 3013450937-2023-00201.The following mdrs were submitted for the same patient: 3013450937-2022-00063, 3013450937-2022-00064, 3013450937-2022-00065, 3013450937-2022-00066, 3013450937-2022-00067 , 3013450937-2022-00068 , 3013450937-2022-00069 , 3013450937-2022-00070, 3013450937-2022-00071, 3013450937-2022-00072, 3013450937-2022-00073.
Event or Problem Description
It was reported that the patient developed an alleged infection.A revision surgery has not yet been scheduled.The patient has the following eleos devices implanted: tibial poly spacer, distal femur, tibial hinge component, distal femur axial pin, stem extension, three male-female midsections, proximal femur, and male-male midsection.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 their index surgery on (b)(6) 2021, where the patient was implanted with eleos distal femoral replacement system.The patient underwent their first revision procedure on (b)(6) 2022 due to trauma and an alleged infection.Refer to (b)(4) for additional information.On (b)(6) 2023, a revision surgery was performed ((b)(4)).During the revision procedure, the following components were replaced: distal femur axial pin, distal femur, tibial hinge component, tibial baseplate tapered screw, tibial baseplate, stem extension, and poly spacer.An agluna coated my3d midsection component and proximal femur component were provided to prevent another occurrence of infection.The patient had the following eleos devices implanted at the time of the second revision: tibial poly spacer, distal femur, tibial hinge component, distal femur axial pin, stem extension, three male-female midsections, proximal femur, and male-male midsection.Visual inspection, dimensional inspection, functional inspection, and material analysis could not be performed as the products were not returned for evaluation.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 and sterilization records, 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.

• Brand Name: ELEOS
• Common Device Name: CEMENTED STEM EXTENSION, 12X100MM, STRAIGHT
• 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: 17704046
• Report Number: 3013450937-2023-00196
• Device Sequence Number: 6746100
• Product Code: KRO
• UDI-Device Identifier: B278KSC12100E0
• UDI-Public: B278KSC12100E0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/07/2023

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: 03/21/2025
• Device Model Number: KSC12100E
• Device Catalogue Number: KSC12100E
• Device Lot Number: 1697272
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2017
• 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 25000007E, ELEOS DISTAL FEMUR; P/N 25001040E, ELEOS MALE FEMALE MIDSECTION; P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001050E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001208E, ELEOS POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N MS-040MM-02M, ELEOS MALE MALE MIDSECTION; P/N PF-2000L-02M, ELEOS PROXIMAL FEMUR; P/N THSMWOS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male