MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 28MM COLLAR,

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by (b)(4), an onkos distributor, that a 74-year-old male patient with an eleos distal femur replacement underwent a revision surgery due to loosening of an eleos 11x152mm press fit segmental stem.The explanted segmental stem was reportedly fixated with bone cement in the femur and had become loose, causing the patient to experience pain in the in the thigh.The surgeon determined that this revision was necessary and opted to build a new construct to ensure optimal fixation.The details of the primary surgery are unknown.A review of historical surgeries at baylor university medical center as well as surgeries previously performed by doctor mollabashy did not yield any additional patient information or historical surgical details related to the patient.As detailed in section 3.5, the ifu and surgical technique documentation identifies elements such as patient contraindications, patient selection factors, surgical procedures/techniques and other precautions/conditions that potentially contribute to adverse effects.The root cause of this complaint was not determined.
Event or Problem Description
It was reported by (b)(4), an onkos distributor, that a 74-year-old male patient with an eleos distal femur replacement underwent a revision surgery due to loosening of an eleos 11x152mm press fit segmental stem.The explanted segmental stem was reportedly fixated with bone cement in the femur and had become loose, causing the patient to experience pain in the in the thigh.The surgeon determined that this revision was necessary and opted to build a new construct to ensure optimal fixation.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 28MM COLLAR,
• 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: 18772029
• Report Number: 3013450937-2024-00040
• Device Sequence Number: 19948866
• Product Code: KRO
• UDI-Device Identifier: B278FB1115203M0
• UDI-Public: B278FB1115203M0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2024

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
• 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: 01/31/2024
• Initial Report FDA Received Date: 02/23/2024
• 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: 11MM X 152MM PRESS FIT SEGMENTAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male