MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM

Lot Number	82299
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent distal femur revision.At this time, no additional information is available.When additional information is received, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
The investigation is in progress, additional information for this event is not known at this time, if additional information is received, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The root cause of this complaint was not determined.Based on the review of device history records, the investigation concluded that the root cause of the segmental stem fracture was not related to the design, manufacture, and/or sterilization of previously implanted components.
Event or Problem Description
A second revision surgery took place on (b)(6) 2023 to remove a fractured canal filling segmental stem (detailed above) which was reportedly cemented into the femur.The 69-year-old female patient's remaining femur was replaced with additional implants, as detailed in the post bill, to create a total femur replacement.Two of the concurrent implants at the time of this segmental stem fracture included male-female midsection 50mm and male-female midsection 60mm which connected the segmental stem to the distal femur.It is unknown whether these two midsections were explanted during this second revision surgery.The following eleos implants were implanted during the second revision surgery: left proximal femur 98mm, male-male midsection 50mm, male-female midsection 70mm, male-female midsection 40mm, femoral head.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS
• Manufacturer (Section D): ONKOS SURGICAL; 77 e. halsey road; parsipanny NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 e. halsey road; parsipanny NJ 07054
• Manufacturer Contact: vandita patel ; 77 e. halsey road; parsipanny, NJ 07054
• MDR Report Key: 18234482
• Report Number: 3013450937-2023-00297
• Device Sequence Number: 12552897
• Product Code: KRO
• UDI-Device Identifier: B278FB1915203M0
• UDI-Public: B278FB1915203M0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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 Lot Number: 82299
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female