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

Model Number	HC-15120-03M
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3013450937-2022-00302
• Device Sequence Number: 7179562
• Product Code: KRO
• UDI-Device Identifier: B278HC1512003M0
• UDI-Public: B278HC1512003M0
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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