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

Catalog Number	KC-1145L
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The complaint involved a patient who underwent a knee revision surgery on (b)(6) 2018.The original surgery is dated (b)(6) 2017.The revision surgery occurred because of reported looseness.During the revision, the original omni size 4+ left cr femoral component, size 4 x 10mm ultra insert, and tibial baseplate retaining bolt were removed and replaced with a size 4 left ps femoral component, size 4 x 14mm ps-c insert, and a 14mm ps-c tibial baseplate retaining bolt.

• 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: 7817843
• Report Number: 1226188-2018-00089
• Device Sequence Number: 11059894
• Product Code: JWH
• UDI-Device Identifier: 00841690100966
• UDI-Public: 00841690100966
• Combination Product (Y/N): N
• PMA/510(K) Number: K060192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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 Expiration Date: 03/31/2021
• Device Catalogue Number: KC-1145L
• Device Lot Number: 22757
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 08/27/2018
• 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; Life Threatening; Required Intervention
• Patient Age: 66 YR