MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL BASEPLATE, SIZE 3

Model Number	TB-2203E-01M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/27/2023
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: #3013450937-2023-00177, #3013450937-2023-00178, #3013450937-2023-00179, #3013450937-2023-00180, #3013450937-2023-00181, #3013450937-2023-00182, #3013450937-2023-00184.
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: stem extension, segmental stem, distal femur, male-female midsection, and tibial baseplate.No additional information regarding this adverse event has been reported.

• Brand Name: ELEOS
• Common Device Name: TIBIAL BASEPLATE, SIZE 3
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17619624
• Report Number: 3013450937-2023-00183
• Device Sequence Number: 7302293
• Product Code: KRO
• UDI-Device Identifier: B278TB2203E01M0
• UDI-Public: B278TB2203E01M0
• 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: 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): 08/24/2023

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: TB-2203E-01M
• Device Catalogue Number: TB-2203E-01M
• Device Lot Number: 90746-005
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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 25001208E, ELEOS POLY SPACER.; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN.; P/N CS-13120-03M, ELEOS SEGMENTAL STEM.; P/N KSC01465E, ELEOS STEM EXTENSION.; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Unknown