MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL BASEPLATE, SIZE 3

Model Number	25002203E
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sales representative has yet to give information on the patient or the implants that were explanted during the event.The failure mode was reported to be instability of the hip.The only eleos components that were in place at the time of the failure were a tibial hinge component and a tibial baseplate, while it is possible that these contributed to the failure, it is more likely that the implants that were not manufactured by onkos were the cause of the failure.If more information is received, a supplement report will be submitted.
Event or Problem Description
A unknown patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to hip instability.The patient's femur had non-eleos implants and hardware such as plates and screws implanted.The patient had an eleos tibial hinge component and tibial baseplate from a previous surgery that was performed on an unknown date.The eleos and non-eleos components were all explanted and replaced with an eleos total femur system.
Event or Problem Description
A patient underwent a surgery to surgery to place eleos implants on 23 march 2021.Eleos implants were removed during a surgery on 19 march 2021 due to metalosis and infection as well as hip instability.
Additional Manufacturer Narrative
This complaint will be capture at onkos under pcr (b)(4).The revision surgery that occured on (b)(6) 2021 was later determined to be related to the complaint investigated by pcr (b)(4).This mdr will be cancelled and a follow up report will be submitted in the mdrs listed below that are associated with pcr (b)(4).Mfr # 3013450937-2021-00041, mfr # 3013450937-2021-00042, mfr # 3013450937-2021-00043, mfr # 3013450937-2021-00044, mfr # 3013450937-2021-00045, mfr # 3013450937-2021-00046, mfr # 3013450937-2021-00047, mfr # 3013450937-2021-00048.

• Brand Name: ELEOS
• Common Device Name: TIBIAL BASEPLATE, SIZE 3
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11708275
• Report Number: 3013450937-2021-00055
• Device Sequence Number: 14426709
• Product Code: KRO
• UDI-Device Identifier: B27825002203E0
• UDI-Public: B27825002203E0
• 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: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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 Model Number: 25002203E
• Device Catalogue Number: 25002203E
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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