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

Model Number KC-1145L

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/16/2020

Event Type  malfunction  

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 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
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIA
• 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: christina rovaldi ; 480 paramount drive; raynham, MA 02767
• MDR Report Key: 10760254
• MDR Text Key: 230224032
• Report Number: 1226188-2020-00190
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00841690100966
• UDI-Public: 00841690100966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060192
• 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: 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
• Device Operator: Health Professional
• Device Model Number: KC-1145L
• Device Catalogue Number: KC-1145L
• Device Lot Number: 35759
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2020
• 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
• Patient Age: 78 YR