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

Model Number 2500BP14E

Device Problem Osseointegration Problem (3003)

Patient Problem No Information (3190)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient underwent a revision surgery due to the segmental stem loosening.

• Brand Name: ELEOS SEGMENTAL STEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDIC; 5677 airline road; arlington TN 38002
• Manufacturer Contact: cristina butrico ; 77 east halsey road; parsippany, NJ 07054 ; 9732645433
• MDR Report Key: 8373716
• MDR Text Key: 137267074
• Report Number: 3013450937-2019-00007
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B2782500BP14E0
• UDI-Public: B2782500BP14E0
• 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: 02/27/2019

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: 2500BP14E
• Device Catalogue Number: 2500BP14E
• Device Lot Number: 1750318
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2018
• 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: 38 YR