MAUDE Adverse Event Report: OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, HEMI

Catalog Number 302800

Device Problem Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Date 06/11/2019

Event Type  Injury  

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 hip revision surgery on (b)(6) 2019.The original surgery is dated (b)(6) 2019.The reason for revision is reported peri-prosthetic fracture.During the revision, the omni distributed stem and cup were removed and replaced.The original omni femoral head was removed and replaced.

• Brand Name: OMNI HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, HEMI
• 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 ; 8004486664
• MDR Report Key: 8759335
• MDR Text Key: 149989269
• Report Number: 1226188-2019-00108
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00841690100355
• UDI-Public: 00841690100355
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082468
• 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: 07/03/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 302800
• Device Lot Number: 29493
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• 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; Required Intervention
• Patient Age: 59 YR