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

Model Number FB-15152-03M

Device Problem Osseointegration Problem (3003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The surgeon was unable to get a good fit with the segmental stem intraoperatively and a larger stem was placed.

• Brand Name: ELEOS SEGMENTAL STEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany, nj
• Manufacturer (Section G): PHILLIPS PRECISION INC.; 7 paul kohner place; elmwood park, nj
• Manufacturer Contact: cristina butrico ; 77 east halsey road; parsippany, nj ; 2645433
• MDR Report Key: 9918334
• MDR Text Key: 186402525
• Report Number: 3013450937-2020-00050
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278FB1515203M0
• UDI-Public: B278FB1515203M0
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2024
• Device Model Number: FB-15152-03M
• Device Catalogue Number: FB-15152-03M
• Device Lot Number: 82295
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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