MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED SEGMENTAL STEM, 11X152MM, BOWED, FLUTED

Model Number CB-11125-03M

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Event Description

It was reported that during a surgery on (b)(6) 2022, it was identified that the inner tray of the cemented bowed segmental stem was no longer sealed, however, the outer tray was still sealed and intact and the surgeon implanted the device.No additional information regarding this malfunction has been reported.

Manufacturer Narrative

The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.

Manufacturer Narrative

This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.

Event Description

It was reported that during a surgery on (b)(6) 2022, it was identified that the inner tray of the cemented bowed segmental stem was no longer sealed, however, the outer tray was still sealed and intact and the surgeon implanted the device.No additional information regarding this malfunction has been reported.

• Brand Name: ELEOS
• Type of Device: CEMENTED SEGMENTAL STEM, 11X152MM, BOWED, FLUTED
• 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: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 16117851
• MDR Text Key: 308578203
• Report Number: 3013450937-2023-00001
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278CB1115203M0
• UDI-Public: B278CB1115203M0
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CB-11125-03M
• Device Catalogue Number: CB-11125-03M
• Device Lot Number: 90757-048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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 Age: 12 YR
• Patient Sex: Female