MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS SEGMENTAL STEM; ELEOS SEGMENTAL STEM - CANAL FILLING

Model Number	FS-18120-03M
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the component met specification.There was no indication that the manufacturing of the components contributed to this complaint.The surgeon stated that he believed that the implant was undersized an a larger one should have been placed.It is unknown if the patient had any medical history or if any event leading up to the revision surgery contributed to the failure.
Event or Problem Description
The patient underwent a revision surgery on (b)(6) 2020 due to loosening of a femoral segmental stem component that resulted in the rotation of a distal femoral component.The segmental stem was replaced along with the distal femur component, the distal femur axial pin, the tibial hinge component, and the poly spacer.The stem extension was thought to be undersized according to the surgeon.

• Brand Name: ELEOS SEGMENTAL STEM
• Common Device Name: ELEOS SEGMENTAL STEM - CANAL FILLING
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany, nj
• MDR Report Key: 10361699
• Report Number: 3013450937-2020-00113
• Device Sequence Number: 2888339
• Product Code: KRO
• UDI-Device Identifier: B278FS1812003M0
• UDI-Public: B278FS1812003M0
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

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: 01/18/2024
• Device Model Number: FS-18120-03M
• Device Catalogue Number: FS-18120-03M
• Device Lot Number: 81698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR