MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; FEMORAL HEAD, SUPER FINISH, 36MM, +0MM TAPER

Model Number	26000026E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2022 due to their femoral head dislocating.During the revision surgery, the surgeon revised the femoral head.No additional information regarding this adverse event has been provided.
Additional Manufacturer Narrative
The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.
Event or Problem Description
An mdr was submitted for this event on 30 november 2022.Additional information was received on 27 january 2023 which confirmed that the device that was reported to have dislocated was not an onkos surgical device.Therefore, there were no alleged malfunctions of onkos surgical devices and this report is being cancelled.
Additional Manufacturer Narrative
An mdr was submitted for this event on 30 november 2022.Additional information was received on 27 january 2023 which confirmed that the device that was reported to have dislocated was not an onkos surgical device.Therefore, there were no alleged malfunctions of onkos surgical devices and this report is being cancelled.

• Brand Name: ELEOS
• Common Device Name: FEMORAL HEAD, SUPER FINISH, 36MM, +0MM TAPER
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline rd; arlington TN 38002
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 15890265
• Report Number: 3013450937-2022-00360
• Device Sequence Number: 17819421
• Product Code: JDI
• UDI-Device Identifier: B27826000026E0
• UDI-Public: B27826000026E0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 26000026E
• Device Catalogue Number: 26000026E
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 FS-16120-03M, ELEOS CANAL-FILLING STEM.; P/N PF-2000L-02M, ELEOS PROXIMAL FEMUR.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female