MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS SEGMENTAL STEM, CEMENTED, STRAIGHT, 15X120MM 32MM COLLAR

Model Number CS-15120-03M

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Little information is known about this complaint. Once more information is obtained, a supplemental report will be submitted.

Event Description

A patient underwent a revision surgery due to unknown reasons. The patient eleos distal femur components in place but they were revised with eleos total femur implants. When more information is known, a supplement report will be submitted.

• Brand Name: ELEOS
• Type of Device: SEGMENTAL STEM, CEMENTED, STRAIGHT, 15X120MM 32MM COLLAR
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC.; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: jonathan zachok ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 12070678
• MDR Text Key: 258601669
• Report Number: 3013450937-2021-00124
• Device Sequence Number: 1
• Product Code: KRO
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CS-15120-03M
• Device Lot Number: 81680
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/25/2021 Patient Sequence Number: 1