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

Model Number	2500R002E
Medical Device Problem Codes	Loss of Osseointegration (2408); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/08/2018
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 3013450937-2018-00045 for the other.The device history records and sterilization batch release records were reviewed and indicated that all components involved met specification.The operation notes and explanted components were requested and it was relayed that the components were disposed of and the operation notes were unable to be obtained.Should additional information be obtained, the report will be supplemented.
Event or Problem Description
Revision surgery performed on eleos resurfacing knee where it appeared on x-rays that the resurfacing femur and stem extension had dissociated.
Additional Manufacturer Narrative
This report is for one of two devices involved in the event, please refer to report 3013450937-2018-00045 for the other.The device history records and sterilization batch release records were reviewed and indicated that all components involved met specification.The operation notes and explanted components were requested and it was relayed that the components were disposed of and the operation notes were unable to be obtained.Should additional information be obtained the report will be supplemented.Further review of patient x-rays revealed that the resurfacing femur had loosened from the bone.
Event or Problem Description
Revision surgery performed on eleos resurfacing knee where it appeared on x-rays that the resurfacing femur and stem extension had dissociated and the resurfacing femur had loosened.

• Brand Name: ELEOS RESURFACING FEMUR
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 7850340
• Report Number: 3013450937-2018-00044
• Device Sequence Number: 1679151
• Product Code: KRO
• UDI-Device Identifier: B2782500R002E0
• UDI-Public: B2782500R002E0
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: 1702636
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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: 44 YR