MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL HINGE COMPONENT, W/O ROTATIONAL STOP

Model Number	25002101E
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the patient developing ulcers around the eleos implants was unable to be definitively determined.It was not reported that the surgeon believed that there was a malfunction of the implants.No information is known about the patient's medical history, and it is unknown if it may have contributed to this complaint.There were no indications that there was a nonconformance during manufacturing or sterilization which would have contributed to the complaint.
Event or Problem Description
A patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6).The surgery was performed due to ulceration around eleos total femur component.During the surgery, the surgeon removed all implants that were implanted at the time as it was decided that the patient's leg would be amputated above the knee.To give the patient's thigh structure, a male-female midsection with a custom end cap implant was placed in the patient's upper leg.

• Brand Name: ELEOS
• Common Device Name: TIBIAL HINGE COMPONENT, W/O ROTATIONAL STOP
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 12441361
• Report Number: 3013450937-2021-00188
• Device Sequence Number: 5156215
• Product Code: KRO
• UDI-Device Identifier: B27825002101E0
• UDI-Public: B27825002101E0
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/08/2021

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: 25002101E
• Device Catalogue Number: 25002101E
• Device Lot Number: 1803752
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 25000001E- ELEOS PROXIMAL FEMUR; 25000007E- ELEOS DISTAL FEMUR; 25000071E- ELEOS MALE-MALE MIDSECTION; 25001090E- ELEOS MALE-FEMALE MIDSECTION, 90MM; 25001140E- ELEOS MALE-FEMALE MIDSECTION 140MM; 25001208E- ELEOS TIBIAL POLY SPACER; 25002111E- ELEOS DISTAL FEMUR AXIAL PIN; 25002203E- ELEOS TIBIAL BASEAPLATE; KSP13140E- ELEOS STEM EXTENSION
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR