MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS¿ LIMB SALVAGE SALVAGE SYSTEM; TIBIAL POLY SPACER 8MM

Catalog Number	25001208E
Medical Device Problem Codes	Fracture (1260); Unintended Movement (3026)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is currently ongoing.Once additional information is received, a supplemental will be submitted accordingly.
Event or Problem Description
It was reported that a patient implanted with an eleos hinge knee construct experienced dislocation of their tibial hinge and poly spacer.It was additionally reported that the eleos poly spacer had fractured.The patient will be revised with an onkos personalized case (custom tibial hinge), to correct the patient's soft tissue laxity.This event will be reported as a serious injury due to the patient requiring a revision procedure.
Additional Manufacturer Narrative
It was reported that a patient implanted with an eleos hinge knee construct experienced dislocation of their tibial hinge and poly spacer.It was additionally reported that the eleos poly spacer had fractured, and the patient had high bmi.The patient was revised with onkos personalized case on (b)(6) 2026.All inspection and manufacturing data of the devices were reviewed; the lot was found to be conforming to specifications, and no manufacturing abnormalities were observed.As detailed in section 2.4, the ifu and surgical technique documentation identifies elements such as patient contraindications, patient selection factors, surgical procedures/techniques and other precautions/conditions that may contribute to adverse effects.Based on the review of device history records, the investigation concluded that the root cause of the reported dislocation/fracture was not likely related to the design or manufacture of the devices.It is possible that patient conditions, such as high patient bmi, could have contributed to issue captured in this complaint.However, based on the available information, a conclusive root cause could not be determined.

• Brand Name: ELEOS¿ LIMB SALVAGE SALVAGE SYSTEM
• Common Device Name: TIBIAL POLY SPACER 8MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey road; parsippany, NJ 07054
• MDR Report Key: 24537028
• Report Number: 3013450937-2026-00103
• Device Sequence Number: 15696078
• Product Code: KRO
• UDI-Device Identifier: B27825001208E0
• UDI-Public: B27825001208E0
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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
• Device Catalogue Number: 25001208E
• Device Lot Number: 2024445
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 05/12/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male