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

Catalog Number	KC-2204R
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/07/2018
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) 2018.The revision surgery occurred because of a reported bone fracture.During the revision, the original omni size 4 right tibial baseplate, size 3 x 10mm congruent insert, and tibial baseplate retaining bolt were removed and replaced with a size 3 modular tibial baseplate, size 3 x 14mm congruent insert, another tibial baseplate retaining bolt, 15mm x 150mm modular stem, size 3 modular tibial augment, 4mm revision tibial augment bolt, and a 12mm modular tibial augment bolt.

• Brand Name: APEX KNEE SYSTEM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBAI
• Manufacturer (Section D): OMNILIFE SCIENCE, INC.; 480 paramount drive; raynham MA 02767
• MDR Report Key: 7920105
• Report Number: 1226188-2018-00073
• Device Sequence Number: 13966135
• Product Code: JWH
• UDI-Device Identifier: 00841690101079
• UDI-Public: 00841690101079
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K060192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/09/2018

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: 02/28/2022
• Device Catalogue Number: KC-2204R
• Device Lot Number: 26072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 09/28/2018
• 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; Required Intervention
• Patient Age: 69 YR