MAUDE Adverse Event Report: OMNILIFE SCIENCE APEX KNEE IMPLANTS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL

Catalog Number KP-22310

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 03/27/2024

Event Type  Injury  

Event Description

A complaint was initiated for a patient who underwent a bi lateral knee revision surgery on (b)(6) 2024.The original surgery date is (b)(6) 2018.The reason for revision is infection.During the revision the tibial inserts and retaining bolts were removed and replaced with new implants.

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.

• Brand Name: APEX KNEE IMPLANTS
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL
• Manufacturer (Section D): OMNILIFE SCIENCE; 480 paramount drive; raynham MA 02767
• Manufacturer (Section G): OMNILIFE SCIENCE; 480 paramount drive; raynham MA 02767
• Manufacturer Contact: jamie demedeiros ; 480 paramount drive; raynham, MA 02767 ; 5088226030
• MDR Report Key: 19080764
• MDR Text Key: 339835484
• Report Number: 1226188-2024-00162
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00841690113560
• UDI-Public: 00841690113560
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/09/2024

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
• Device Expiration Date: 04/05/2023
• Device Catalogue Number: KP-22310
• Device Lot Number: 30234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: KP-20010 LOTS 29405, 30629; KP-22310 LOT 29914
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male