MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TIBIAL HINGE COMPONENT; PROSTHESIS, KNEE

Model Number	25002101E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for one of three devices involved in this event, please refer to report 3013450937-2020-00010 and 3013450937-2020-00012 for the other devices.The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The explanted components were unable to be obtained for further analysis.Additionally, it was unable to be confirmed whether the component dislocated.Should additional information be obtained the report will be supplemented.
Event or Problem Description
Patient alleged that their tibial hinge component dislocated, but when they visited their surgeon it appeared that it had reduced itself without surgical intervention.Patient's incision site was extremely red and inflamed and a revision surgery was performed.

• Brand Name: ELEOS TIBIAL HINGE COMPONENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany, nj
• MDR Report Key: 9700011
• Report Number: 3013450937-2020-00011
• Device Sequence Number: 14168179
• Product Code: KRO
• UDI-Device Identifier: B27825002101E0
• UDI-Public: B27825002101E0
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: 1736498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/12/2020
• 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: 56 YR