MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; PROXIMAL TIBIA

Model Number	PT-20000-02M
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	07/25/2023
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: #3013450937-2023-00171, #3013450937-2023-00172, #3013450937-2023-00173, #3013450937-2023-00174, #3013450937-2023-00175, #3013450937-2023-00176.
Event or Problem Description
It was reported that a patient with an eleos proximal tibia replacement system is infected.The patient will be undergoing a revision surgery, however, it has not yet been scheduled.Attempts have been made and no further information has been made available.

• Brand Name: ELEOS
• Common Device Name: PROXIMAL TIBIA
• 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: 17603771
• Report Number: 3013450937-2023-00170
• Device Sequence Number: 20385030
• Product Code: KRO
• UDI-Device Identifier: B278PT2000002M0
• UDI-Public: B278PT2000002M0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/23/2023

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: PT-20000-02M
• Device Catalogue Number: PT-20000-02M
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 11/22/2023
• 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: ELEOS RESURFACING FEMUR; ELEOS RESURFACING FEMUR AXIAL PIN; ELEOS SEGMENTAL STEM; ELEOS STEM EXTENSION; ELEOS TIBIAL HINGE COMPONENT; ELEOS TIBIAL POLY SPACER
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown