MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED STRAIGHT SEGMENTAL STEM, 15X120MM

Model Number HC-15120-03M

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/16/2022

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 distal 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.It was reported that the surgeon achieved good fixation when implanting the stem.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 adverse event 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.H6: investigation conclusions code updated to 4315: cause not established.

Event Description

It was reported that during a distal femoral replacement surgery on 16 september 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.It was reported that the surgeon achieved good fixation when implanting the stem.No adverse events have been reported from this malfunction.

• Brand Name: ELEOS
• Type of Device: CEMENTED STRAIGHT SEGMENTAL STEM, 15X120MM
• 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: 15610746
• MDR Text Key: 304882337
• Report Number: 3013450937-2022-00302
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278HC1512003M0
• UDI-Public: B278HC1512003M0
• 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: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HC-15120-03M
• Device Catalogue Number: HC-15120-03M
• Device Lot Number: 84550-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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
• Treatment: P/N 25000007E, ELEOS DISTAL FEMUR; P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001050E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001208E, ELEOS POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N KSC01530E, ELEOS STEM EXTENSION; P/N TB-2202E-01M, ELEOS TIBIAL BASEPLATE; P/N THSMWOS01M, ELEOS TIBIAL HINGE COMPONENT
• Patient Age: 80 YR
• Patient Sex: Female