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

Model Number	25002101E
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the failure was unable to be determined.The patient has undergone a previous revision surgery for the same issue.The patient's medical history is unknown, and it is unknown whether the patient sustained a trauma prior to the failure.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 nonconformance.
Event or Problem Description
A (b)(6) male patient underwent a revision surgery on (b)(6) 2020 performed by dr.(b)(6) due to scar tissue forming around the patient's patella which was causing pain, stiffness, and a loss of range of motion of the knee.The surgeon debrided the scar tissue but did not replace the implants as they were deemed to not be affected and there were no failures found intraoperatively.

• 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: 10762595
• Report Number: 3013450937-2020-00164
• Device Sequence Number: 19114042
• Product Code: KRO
• UDI-Device Identifier: B27825002101E0
• UDI-Public: B27825002101E0
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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: 06/19/2026
• Device Model Number: 25002101E
• Device Catalogue Number: 25002101E
• Device Lot Number: 1736499
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2020
• 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: Other; Required Intervention
• Patient Age: 39 YR