MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; ELEOS TIBIAL BASEPLATE

Catalog Number	25002201E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Joint Laxity (4526); Limb Pain (4836)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation was concluded on this event on (b)(6) 2023.During this revision procedure, an eleos tibial hinge component, eleos tibial poly spacer, and eleos tibial baseplate were revised, as the patient was experiencing patella baja in the left knee joint.The patient was experiencing patella baja, resulting in the need to change the alignment of the hardware to allow for proper tracking of the patella during flexion and extension.In this case, the three eleos components were replaced with custom non-onkos devices.The explanted devices were not returned for evaluation.The lot number of the tibial poly spacer is not known.Therefore, a review of work order and sterilization batch record could not be completed as the device information is not known.The root cause of the patella baja condition could not be determined conclusively.Patella baja is the condition of a patient's patella lying lower than intended, which can cause pain and restricted range of motion.The cause of this condition could have been due to multiple factors- insufficient alignment/placement of the patella intra-operatively, improper selection or positioning of components intra-operatively, post-operative trauma, etc.However, based on the available information, a root cause could not be determined conclusively.The following mdrs were submitted for this event: 3013450937-2023-00122, 3013450937-2023-00122-001 , 3013450937-2023-00205.
Event or Problem Description
It was identified on (b)(6) 2023 that a patient underwent a revision procedure in 2017.The patient was experiencing patella baja in the left knee joint.In this case, eleos components were replaced with non-onkos devices.On (b)(6) 2023, through investigation of mdr 3013450937-2023-00122 , additional information was received regarding components which were revised.- an eleos tibial hinge component, eleos tibial poly spacer, and eleos tibial baseplate was revised.This record captures the eleos tibial baseplate mdr 3013450937-2023-00122 captures the eleos tibial hinge component.Mdr 3013450937-2023-00205 captures the eleos tibial poly spacer.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS TIBIAL BASEPLATE
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 17917360
• Report Number: 3013450937-2023-00206
• Device Sequence Number: 2971565
• Product Code: KRO
• UDI-Device Identifier: B27825002201E0
• UDI-Public: B27825002201E0
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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 Catalogue Number: 25002201E
• 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: 09/13/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown