MAUDE Adverse Event Report: OMNILIFE SCIENCE, INC. APEX KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIA

Model Number	KC-1145L
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
A complaint was initiated for a patient who underwent a knee surgery on (b)(6) 2020.During the surgery the patient was implanted with left components into a right knee.

• Brand Name: APEX KNEE SYSTEM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIA
• Manufacturer (Section D): OMNILIFE SCIENCE, INC.; 480 paramount drive; raynham MA 02767
• MDR Report Key: 10760254
• Report Number: 1226188-2020-00190
• Device Sequence Number: 1901880
• Product Code: JWH
• UDI-Device Identifier: 00841690100966
• UDI-Public: 00841690100966
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2025
• Device Model Number: KC-1145L
• Device Catalogue Number: KC-1145L
• Device Lot Number: 35759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR