MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM, CANAL FILLING, BOWED, 15X152MM

Model Number	FB-15152-03M
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the intraoperative issue was unable to be definitively determined.Due to a larger stem being placed after the complaint product was explanted, the issue may have been selection of an implant that was too small for the patient anatomy.However, no information is available to corroborate that claim.The sales representative was unable to provide more information on the issue.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 patient underwent a surgery on (b)(6) 2019 performed by dr.(b)(6) to place eleos components.During the surgery, the surgeon attempted to place a 15x152 mm segmental stem into the femur, but it was explanted during the surgery for an unknown reason.The surgeon then placed a 16x152 mm segmental stem into the femur successfully.It is unknown how long of a delay this issue caused intraoperatively.

• Brand Name: ELEOS
• Common Device Name: SEGMENTAL STEM, CANAL FILLING, BOWED, 15X152MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11809911
• Report Number: 3013450937-2021-00069
• Device Sequence Number: 3149008
• Product Code: KRO
• UDI-Device Identifier: B278FB1515203M0
• UDI-Public: B278FB1515203M0
• 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: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 03/04/2024
• Device Model Number: FB-15152-03M
• Device Catalogue Number: FB-15152-03M
• Device Lot Number: 82295
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/11/2021
• 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: 58 YR