MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; SEGMENTAL COLLAR STEM, CEMENTED 17X100MM

Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by (b)(6), an onkos sales representative, that a patient with an eleos distal femur replacement suffered from loosening of the femoral 17x100mm cemented segmental stem and associated reduced resection collar.The revision surgery was performed by doctor (b)(6) on (b)(6) 2023.On 20 february 2024 and 21 february 2024, additional details regarding the primary surgery and patient information were requested.On 21 february 2024, (b)(6) confirmed that additional details with respect to the primary surgery and patient information remain unknown.
Additional Manufacturer Narrative
It was reported by (b)(6), an onkos sales representative, that a patient with an eleos distal femur replacement suffered from loosening of the femoral 17x100mm cemented segmental stem and associated reduced resection collar.The revision surgery was performed by doctor lutes on (b)(6) 2023.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.The following mdrs are related to this adverse event: 3013450937-2023-00343, 3013450937-2023-00344.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: SEGMENTAL COLLAR STEM, CEMENTED 17X100MM
• 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: 18769231
• Report Number: 3013450937-2023-00343
• Device Sequence Number: 7795260
• Product Code: KRO
• UDI-Device Identifier: B278HC1712003M0
• UDI-Public: B278HC1712003M0
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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: 12/01/2023
• 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: MODULAR REDUCED RESECTION COLLAR, 36MM X 40MM; SEGMENTAL COLLAR STEM, CEMENTED, 17MM X 100MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown