MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MALE-FEMALE MIDSECTION, 70MM

Model Number	25001070E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	05/17/2022
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: #3013450937-2022-00178, #3013450937-2022-00179, #3013450937-2022-00181, #3013450937-2022-00182, #3013450937-2022-00183, #3013450937-2022-00184, #3013450937-2022-00185.
Event or Problem Description
It was reported that the patient developed an alleged infection.The patient underwent a revision surgery on (b)(6) 2022 where the following eleos implants were revised: tibial hinge component, distal femur axial pin, distal femur, male-female midsection, and poly spacer.The following implants remain implanted: cemented segmental stem, tibial baseplate, and cemented stem extension.Multiple attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that the patient developed an alleged infection.The patient underwent a revision surgery on (b)(6) 2022 where the following eleos implants were revised: tibial hinge component, distal femur axial pin, distal femur, male-female midsection, and poly spacer.The following implants remain implanted: cemented segmental stem, tibial baseplate, and cemented stem extension.Multiple attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the alleged infection could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.

• Brand Name: ELEOS
• Common Device Name: MALE-FEMALE MIDSECTION, 70MM
• 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: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 14649551
• Report Number: 3013450937-2022-00180
• Device Sequence Number: 4904817
• Product Code: KRO
• UDI-Device Identifier: B27825001070E0
• UDI-Public: B27825001070E0
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 08/15/2022

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: 25001070E
• Device Catalogue Number: 25001070E
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ELEOS CEMENTED SEGMENTAL STEM; ELEOS CEMENTED STEM EXTENSION; ELEOS TIBIAL BASEPLATE; P/N 25000009E, ELEOS DISTAL FEMUR; P/N 25001208E, ELEOS POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N THSWMRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female