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

Model Number	2500SP14E
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Cancer (3262)
Date of Event	05/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record and sterilization batch release record were reviewed, which indicated that the component met specification.The operation notes, from the patient's previous surgery, has been requested.The revision surgery has not been scheduled, but it has been requested that the explanted stem be returned to the manufacturer for further investigation.This investigation is currently ongoing and should additional information be obtained the report will be supplemented.
Event or Problem Description
Patient x-rays revealed aseptic loosening of the segmental stem.
Additional Manufacturer Narrative
This complaint has been closed as the patient's revision surgery has not been scheduled.In the event that a revision surgery does occur the complaint will be re-opened and this report will be supplemented.
Event or Problem Description
Patient' previous surgery, on (b)(6) 2018, involved the removal of a tumor of the distal tibia and the placement of a guardian custome component with an eleos stem.

• Brand Name: ELEOS SEGMENTAL STEM, CANAL FILLING
• Common Device Name: PROSTHESIS, STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 7586481
• Report Number: 3013450937-2018-00010
• Device Sequence Number: 11151865
• Product Code: KRO
• UDI-Device Identifier: B2782500SP14E0
• UDI-Public: B2782500SP14E0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2018

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: 03/16/2025
• Device Model Number: 2500SP14E
• Device Catalogue Number: 2500SP14E
• Device Lot Number: 1703609
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 05/27/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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: 43 YR