MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; RESURFACING FEMUR AXIAL PIN, SIZE3

Model Number	25002113E
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the patient developing metallosis was unable to be definitively determined.The sales representative did not give information on the condition of the explanted components.The components were discarded, and no analysis will be conducted.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or the sterilization of the implants or a nonconformance.
Event or Problem Description
A (b)(6) male patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to the patient having metallosis.During the surgery, the surgeon removed all of the implants that contained poly components and replaced them with new implants.The resurfacing femur and tibial baseplate, which are the interfacing components with the explanted implants, were not explanted.

• Brand Name: ELEOS
• Common Device Name: RESURFACING FEMUR AXIAL PIN, SIZE3
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11783091
• Report Number: 3013450937-2021-00064
• Device Sequence Number: 11677238
• Product Code: KRO
• UDI-Device Identifier: B27825002113E0
• UDI-Public: B27825002113E0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2026
• Device Model Number: 25002113E
• Device Catalogue Number: 25002113E
• Device Lot Number: 1764141
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR