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

Model Number KP-24514

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Damage to Ligament(s) (1952)

Event Date 01/16/2024

Event Type  Injury  

Event Description

A complaint was initiated for a patient who underwent a knee revision surgery on (b)(6) 2024.The original surgery occurred on (b)(6) 2023, the reason for revision is reported torn retinaculum.During the revision, the original tibial insert and retaining bolt were removed and replaced with new components.

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.According to the intake form, the products are not available for return and evaluation.A 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.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
• Type of Device: 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 02767
• MDR Report Key: 18647593
• MDR Text Key: 334618180
• Report Number: 1226188-2024-00153
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112891
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KP-24514
• Device Lot Number: 37280
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/16/2024
• Date Manufacturer Received: 01/16/2024
• Date Device Manufactured: 12/11/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 118 KG