MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING STRAIGHT STEM, 15X120MM

Model Number FS-15120-03M

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Fall (1848)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2022-00167.

Event Description

It was reported that the patient fell for an unknown reason and the distal femur dissociated from the canal-filling segmental stem.The patient underwent a revision surgery on (b)(6) 2022 where the following implants were revised: distal femur, distal femur axial pin, tibial hinge component, poly spacer, and proximal tibia.No additional information regarding this event have been provided.

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 the patient fell for an unknown reason and the distal femur dissociated from the canal-filling segmental stem.The patient underwent a revision surgery on (b)(6) 2022 where the following implants were revised: distal femur, distal femur axial pin, tibial hinge component, poly spacer, and proximal tibia.No additional information regarding this event have been provided.

• Brand Name: ELEOS
• Type of Device: CANAL-FILLING STRAIGHT 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: 14465884
• MDR Text Key: 292482390
• Report Number: 3013450937-2022-00168
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278FS1512003M0
• UDI-Public: B278FS1512003M0
• 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: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-15120-03M
• Device Catalogue Number: FS-15120-03M
• Device Lot Number: 85214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• 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 25001208E, ELEOS POLY SPACER.; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN.; P/N FS-11120-03M, ELEOS CANAL-FILLING STEM.; P/N PT-20000-02M, ELEOS PROXIMAL TIBIA.; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male