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

Model Number	25002101E
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the patient developing scar tissue was unable to be determined.The patient has undergone two revision surgeries due to scar tissue developing around the patella.The patient's medical history is unknown.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) patient underwent a revision surgery on (b)(6) 2019 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 and revised a distal femur component, a tibial poly spacer, a tibial hinge component, and a distal femur axial pin with identical implants.
Additional Manufacturer Narrative
The root cause for the patient developing scar tissue was unable to be determined.The patient has undergone two revision surgeries due to scar tissue developing around the patella.The patient's medical history is unknown.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.The complaint was reported to onkos on (b)(6) 2020.
Event or Problem Description
A 39-year-old male patient underwent a revision surgery on (b)(6) 2019 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 and revised a distal femur component, a tibial poly spacer, a tibial hinge component, and a distal femur axial pin with identical implants.

• 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: 10843770
• Report Number: 3013450937-2020-00174
• Device Sequence Number: 2959744
• 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: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 09/14/2025
• Device Model Number: 25002101E
• Device Catalogue Number: 25002101E
• Device Lot Number: 1711285
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 11/16/2020
• 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: Required Intervention
• Patient Age: 39 YR