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

Lot Number	1892325
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by (b)(4), an onkos distributor, that a 43-year-old female patient with an eleos distal femur replacement underwent a revision due to loosening of the eleos cemented segmental stem that was inserted into the femur without the use of bone cement.The reported information also indicated that the eleos tibial baseplate was also inserted without bone cement and the surgeon suspected that the patient had a peri-operative infection.
Additional Manufacturer Narrative
Based on the review of device history records, the investigation concluded that the root cause of the reported loosening and perioperative joint infection was not related to the design, manufacture, and/or sterilization of the revised eleos devices.Based on the reported information, the most probable root cause of the femoral cemented segmental stem loosening is the failure to use bone cement to fixate the device as detailed in the instructions for use.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: TIBIAL ROTATIONAL HINGE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: yara neurauter ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 20476178
• Report Number: 3013450937-2024-00321
• Device Sequence Number: 7603377
• Product Code: KRO
• UDI-Device Identifier: B278THSMWOS01M0
• UDI-Public: B278THSMWOS01M0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 10/17/2024

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 Lot Number: 1892325
• 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: 09/18/2024
• Initial Report FDA Received Date: 10/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AP DISTAL FEMUR AXIAL PIN; DF DISTAL FEMUR; HC CEMENTED MODULAR SEGMENTAL STEM; HR MODULAR COLLAR LOCKING RING; PB MODULAR PLASMA COLLAR; PS TIBIAL POLY SPACER; TB TIBIAL BASEPLATE; TH TIBIAL ROTATIONAL HINGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female