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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMNILIFE SCIENCE APEX KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL
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OMNILIFE SCIENCE APEX KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL Back to Search Results
Catalog Number EC:35020
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/01/2025
Type of Reportable Event Serious Injury
Event or Problem Description
A complaint was initiated for a patient who underwent a knee revision surgery on (b)(6) 2025.The original surgery date (b)(6) 2024.The reason for revision is reported infection.During the revision the tibial insert and bolt were removed and replaced with new implants.
 
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.
 
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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 Key23495598
Report Number1226188-2025-00055
Device Sequence Number12987795
Product Code JWH
UDI-Device Identifier00841690132011
UDI-Public00841690132011
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K201611
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Company Representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/07/2025
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 Catalogue NumberEC:35020
Device Lot Number551321
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/02/2025
Initial Report FDA Received Date11/07/2025
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured11/26/2023
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
REF: (B)(4).LOT NUMBER: 40201.
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient SexUnknown
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