MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Hypersensitivity/Allergic reaction (1907); Joint Laxity (4526); Insufficient Information (4580)

Event Date 08/08/2023

Event Type  Injury  

Event Description

It was reported that the patient had a loose stem and a potential nickel allergy.The patient will be undergoing a revision surgery, however, it has not been scheduled yet.Attempts have been made and no further information was made available.

Manufacturer Narrative

The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.

Manufacturer Narrative

The patient underwent a revision surgery on 11 october 2023 due to a suspected stem loosening and nickel allergy.An eleos dfr was revised with custom implants via onkos my 3d case # (b)(4) with tin coating.It is unknown when the original surgery took place and what was implanted.Ultimately, the root cause of the patient's infection was unable to be determined.A review of the work order and sterilization batch release record for the product involved could not be performed as the product information is unknown.However, device history records are reviewed prior to releasing products to the field to verify that the products have been manufactured to their required specification, as well as inspected to ensure compliance with their engineering drawing.If additional information is received regarding this event, this complaint will be updated accordingly.

• Brand Name: ELEOS
• Type of Device: SEGMENTAL STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: vandita patel ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17704565
• MDR Text Key: 322924587
• Report Number: 3013450937-2023-00202
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Female