MAUDE Adverse Event Report: OMNILIFE SCIENCE INC. APEX KNEE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	KC-35030
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant made no indication of any omnilife science device malfunction or deficiency related to the identity, quality, durability, reliability, safety, effectiveness or device performance contributing to the adverse event.Review of the manufacturing documentation and sterilization documentation for the devices in question revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.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.
Event or Problem Description
A complaint was initiated for a patient who underwent a knee revision surgery on (b)(6) 2024.The original surgery date is (b)(6) 2016.The reason for revision is infection.During the revision the insert and bolt were removed and replaced with new implants.

• Brand Name: APEX KNEE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): OMNILIFE SCIENCE INC.; 480 paramount drive; raynham MA 02767
• Manufacturer (Section G): OMNILIFE SCIENCE INC.; 480 paramount drive; raynham MA 02767
• Manufacturer Contact: jamie demedeiros ; 480 paramount drive; raynham, MA
• MDR Report Key: 18682610
• Report Number: 1226188-2024-00157
• Device Sequence Number: 12310579
• Product Code: JWH
• UDI-Device Identifier: 00841690101253
• UDI-Public: 00841690101253
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2024

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: 06/30/2021
• Device Model Number: KC-35030
• Device Lot Number: 23776
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 02/10/2024
• Date Device Manufactured: 06/30/2016
• 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: Required Intervention; Hospitalization
• Patient Sex: Female