MAUDE Adverse Event Report: OMNILIFE SCIENCE APEX KNEE SYSTEM; CR FEMUR TIN COATED SIZE 4+ LEFT

Model Number	KC-1145L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per comp (b)(4) initial report.Additional information, including a description of the nature of the pain, if other symptoms were observed and if an infection was ruled out, post-operative x-rays, an update on the patient and if a revision surgery was planned or being considered, has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing and sterilisation records will be identified and reviewed.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
Unbearable pain 18 days post surgery following an apex total knee replacement.
Additional Manufacturer Narrative
(b)(4) final report.Additional information, including a description of the nature of the pain, if other symptoms were observed and if an infection was ruled out, post-operative x-rays, an update on the patient and if a revision surgery was planned or being considered, has been requested in order to progress with the investigation of this event, however, corin vigilance was made aware that no answers should be expected.The appropriate device details were provided and the relevant device manufacturing and sterilisation records have identified and reviewed.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to the reported pain.Based on the above, no further investigation can be conducted.Therefore, this case is now considered closed.The root cause of the reported pain could not be determined.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
Unbearable pain 18 days post surgery following an apex total knee replacement.

• Brand Name: APEX KNEE SYSTEM
• Common Device Name: CR FEMUR TIN COATED SIZE 4+ LEFT
• 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: 23665998
• Report Number: 1226188-2025-00058
• Device Sequence Number: 15678922
• Product Code: JWH
• UDI-Device Identifier: 00841690100966
• UDI-Public: 00841690100966
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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 Model Number: KC-1145L
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 593118
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INSERT: KC-36041, 592059,; INSERT: KC-36041, 592059,; PATELLA: KC-40358, 598389,; PATELLA: KC-40358, 598389,; PRIMARY TIBIA BASEPLATE: KC-2205L, 584158,; PRIMARY TIBIA BASEPLATE: KC-2205L, 584158,; RETAINING BOLT: KP-53000, 594796,; RETAINING BOLT: KP-53000, 594796.
• Patient Age: 81 YR
• Patient Sex: Male