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

Model Number KC-36038

Device Problem Insufficient Information (3190)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/08/2020

Event Type  Injury  

Event Description

A complaint was initiated for a patient who underwent a knee revision surgery on (b)(6) 2020.The original surgery date is unknown.The tibial insert was changed during a patellar tendon repair.During the revision, the original tibial insert and retaining bolt were removed and replaced with new components.

• Brand Name: APEX KNEE SYSTEM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIA
• Manufacturer (Section D): OMNILIFE SCIENCE, INC.; 480 paramount drive; raynham, ma
• Manufacturer (Section G): OMNILIFE SCIENCE, INC.; 480 paramount drive; raynham, ma
• Manufacturer Contact: christina rovaldi ; 480 paramount drive; raynham, ma
• MDR Report Key: 10532063
• MDR Text Key: 206986579
• Report Number: 1226188-2020-00160
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00841690101642
• UDI-Public: 00841690101642
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: KC-36038
• Device Catalogue Number: KC-36038
• Device Lot Number: 5980
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2009
• 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: 81 YR