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

Model Number 25000007E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The component was unable to be obtained for further analysis.Should additional information be obtained the report will be supplemented.

Event Description

Patient was experiencing pain and surgical intervention was required to revise implants.

• Brand Name: ELEOS DISTAL FEMUR
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS, INC.; 5677 airline road; arlington TN 38002
• Manufacturer Contact: cristina butrico ; 77 e halsey road; parsippany, NJ 07054
• MDR Report Key: 11088101
• MDR Text Key: 228177774
• Report Number: 3013450937-2020-00191
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825000007E0
• UDI-Public: B27825000007E0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2020

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
• Device Operator: Health Professional
• Device Model Number: 25000007E
• Device Catalogue Number: 25000007E
• Device Lot Number: 1778819
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR