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

Model Number	26000026E
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the patient's hip dislocating was unable to be definitively determined.The surgeon revised the implants with the same size implants.The patient's medical history is not known; therefore, it is unable to be determined if their medical history contributed to the hip dislocation.However, based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or the sterilization of the implants or a non-conformance.
Event or Problem Description
A patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to their femoral head component becoming dislocated from their gladiator acetabular cup.During the revision surgery, both components were revised.It is unknown if the patient sustained an injury causing the dislocation or if there was another contributing factor.Both components were revised with implants of the same size.The patient also had an eleos male female midsection and a canal filling segmental stem as well as a guardian proximal femoral neck.However, these implants were not revised.The gladiator acetabular cup was not manufacturing by onkos; therefore, it will not be investigated in this complaint.There is no evidence to show that the eleos implants that were not revised may have contributed to this event; therefore, they will not be investigated in this report.

• Brand Name: ELEOS
• Common Device Name: FEMORAL HEAD, SUPER FINISH, 36MM TAPER, +0MM
• Manufacturer (Section D): ONKOS SURGICAL INC.; 77 e halsey rd; parsippany NJ 07054
• MDR Report Key: 12618889
• Report Number: 3013450937-2021-00230
• Device Sequence Number: 1308913
• Product Code: JDI
• UDI-Device Identifier: B27826000026E0
• UDI-Public: B27826000026E0
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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 Expiration Date: 05/18/2025
• Device Model Number: 26000026E
• Device Catalogue Number: 26000026E
• Device Lot Number: 1711958
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention