MAUDE Adverse Event Report: OMNIlife Science Apex Knee System; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL

Catalog Number	KC-2304R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
We were notified on 11/jul/2026 of a planned suregry due to tibial tray breakage.Revison surgery has not taken place as of this report.
Additional Manufacturer Narrative
This report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.A follow-up/final report will be filed once all complementary information is provided.

• Brand Name: Apex Knee System
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL
• Manufacturer (Section D): OMNIlife Science; 480 paramount dr; raynham MA 02767
• Manufacturer (Section G): OMNIlife Science; 480 paramount dr; raynham MA 02767
• Manufacturer Contact: jamie demedeiros ; 480 paramount dr; raynham, MA 02767
• MDR Report Key: 50161235
• Report Number: 1226188-2026-00030
• Device Sequence Number: 9092354
• Product Code: JWH
• UDI-Device Identifier: 00841690104469
• UDI-Public: 00841690104469
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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
• Device Expiration Date: 10/02/2024
• Device Catalogue Number: KC-2304R
• Device Lot Number: 32871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown