MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; MODULAR REDUCED RESECTION COLLAR 36X40MM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Laxity (4526)

Event Date 12/07/2023

Event Type  Injury  

Event Description

It was reported by (b)(4), 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 (b)(6) 2024, (b)(4) confirmed that additional details with respect to the primary surgery and patient information remain unknown.

Manufacturer Narrative

It was reported by (b)(4), 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.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.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Type of Device: MODULAR REDUCED RESECTION COLLAR 36X40MM
• 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: 18769228
• MDR Text Key: 336186115
• Report Number: 3013450937-2023-00344
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODULAR REDUCED RESECTION COLLAR, 36MM X 40MM.; SEGMENTAL COLLAR STEM, CEMENTED, 17MM X 100MM.
• Patient Outcome(s): Required Intervention