MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER, 16MM

Model Number	25001216E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/25/2023
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: 3013450937-2023-00208, 3013450937-2023-00210.
Event or Problem Description
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 component, tibial poly spacer, and resurfacing femur axial pin.The date of this patient's original surgery is unknown, therefore, it is not known if there are other implants placed at the time of this alleged infection.Attempts have been made and no further information has been made available.
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 component, tibial poly spacer, and resurfacing femur axial pin.The date of this patient's original surgery is unknown, therefore, it is not known if there are other implants placed at the time of this alleged infection.Ultimately, the root cause of the patient's infection was unable to be determined.A review of the work order and sterilization batch release record for the product involved could not be performed as the product information is unknown.However, device history records are reviewed prior to releasing products to the field to verify that the products have been manufactured to the required specifications, as well as inspected to ensure compliance with their engineering drawing.If additional information is received regarding this event, this complaint will be updated accordingly.

• Brand Name: ELEOS
• Common Device Name: TIBIAL POLY SPACER, 16MM
• 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: 17801467
• Report Number: 3013450937-2023-00209
• Device Sequence Number: 12427814
• Product Code: KRO
• UDI-Device Identifier: B27825001216E0
• UDI-Public: B27825001216E0
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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): 09/22/2023

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 Model Number: 25001216E
• Device Catalogue Number: 25001216E
• 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: 08/25/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 12/20/2023
• 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: P/N 25002114E, ELEOS RESURFACING FEMUR AXIAL PIN; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR
• Patient Sex: Unknown