MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; ELEOS CEMENTED SEGMENTAL STEM

Catalog Number	CS-13120-03M
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation for this event is ongoing.When additional information is received, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that a patient will be revised due to an alleged infection.The following implants will be revised: eleos proximal femur, eleos male-female midsection, and eleos cemented segmental stem.The date of the revision surgery has not been scheduled at this time.This event will be reportable as a serious injury, as the implanted devices will be revised.This report captures the eleos cemented segmental stem.
Additional Manufacturer Narrative
It was reported that a patient will be revised due to an alleged infection.The following implants will be revised and replaced: eleos proximal femur, eleos male-female midsection, and eleos cemented segmental stem.The root cause of this complaint could not be determined.Based on the review of device history records, the investigation concluded that the root cause of the reported infection was not likely related to the design, manufacture, and/or sterilization of the implanted eleos implants.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS CEMENTED SEGMENTAL STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 19281846
• Report Number: 3013450937-2024-00129
• Device Sequence Number: 6358491
• Product Code: KRO
• UDI-Device Identifier: B278CS1312003M0
• UDI-Public: B278CS1312003M0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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
• Device Catalogue Number: CS-13120-03M
• Device Lot Number: P230618
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male