MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED SEGMENTAL STEM, 13MM X 120MM, STRAIGHT, FLUTED

Model Number HC-13120-03M

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a proximal femoral replacement surgery on (b)(6) 2022, the surgeon implanted the modular collar cemented stem without a modular collar or collar locking ring.This type of stem is intended to be implanted with a modular collar and collar locking ring.No adverse events have been reported from this malfunction.

Event Description

It was reported that during a proximal femoral replacement surgery on (b)(6) 2022, the surgeon implanted the modular collar cemented stem without a modular collar or collar locking ring.This type of stem is intended to be implanted with a modular collar and collar locking ring.No adverse events have been reported from this malfunction.

Manufacturer Narrative

This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the issue could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: h3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4117: device not accessible for testing.H6: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4111: communication/interviews.H6: type of investigation code updated to 4109: historical data analysis.H6: investigation findings code updated to 3221: no findings available.

• Brand Name: ELEOS
• Type of Device: CEMENTED SEGMENTAL STEM, 13MM X 120MM, STRAIGHT, 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: danielle pierce ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 16492255
• MDR Text Key: 310807522
• Report Number: 3013450937-2023-00040
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278HC1312003M0
• UDI-Public: B278HC1312003M0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203815
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HC-13120-03M
• Device Catalogue Number: HC-13120-03M
• Device Lot Number: 92104-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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
• Treatment: 25001040E ELEOS MALE-FEMALE MIDSECTION 40MM; 25001060E ELEOS MALE-FEMALE MIDSECTION 60MM; PF-2000L-02M PROXIMAL FEMUR, 98MM, LEFT, 135 DEG
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male