MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS RESURFACING FEMUR SIZE 2 RIGHT; PROSTHESIS, KNEE

Model Number	2500R002E
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for one of two devices involved in the event, please refer to report 3013450937-2018-00021 for the others.The device history record and sterilization batch release record were reviewed and indicated that the components involved met specification.The operation notes and patient x-rays were obtained for review.It was relayed by the sales representative that the explanted components will be returned for further analysis.Should additional information be obtained the report will be supplemented.
Event or Problem Description
Patient underwent a revision surgery due to instability.During intraoperative inspection it was found that the resurfacing femur had loosened.

• Brand Name: ELEOS RESURFACING FEMUR SIZE 2 RIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 7765403
• Report Number: 3013450937-2018-00020
• Device Sequence Number: 11063820
• Product Code: KRO
• UDI-Device Identifier: B2782500R002E0
• UDI-Public: B2782500R002E0
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2018

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: 2500R002E
• Device Catalogue Number: 2500R002E
• Device Lot Number: 1700341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/08/2018
• 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: 42 YR