MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TIBIAL POLY SPACER 16MM; PROSTHESIS, KNEE

Model Number	25001216E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medical device report (mdr) was initiated as part of a retrospective assessment of complaints under onkos surgical capa (b)(4).As part of this assessment, onkos surgical re-evaluated all complaints received to ensure mdr's were filed when required.The results of this retrospective assessment prompted onkos surgical to file this report.This report is for one of three devices involved in this event, please refer to report 3013450937-2018-00022 and 3013450937-2018-00024 for the others.The device history records and sterilization batch release records were reviewed and indicated that the components involved met specification.It was determined that the adverse event was not related to the manufacture of the implants or a non-conformance and this complaint has been closed.Should additional information be obtained, the complaint will be re-opened, and this report will be supplemented.
Event or Problem Description
Patient underwent a revision surgery due to an alleged infection.

• Brand Name: ELEOS TIBIAL POLY SPACER 16MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 7828562
• Report Number: 3013450937-2018-00023
• Device Sequence Number: 1517582
• Product Code: KRO
• UDI-Device Identifier: B27825001216E0
• UDI-Public: B27825001216E0
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2018

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: 03/17/2025
• Device Model Number: 25001216E
• Device Catalogue Number: 25001216E
• Device Lot Number: 1699788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/29/2018
• 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: 76 YR