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

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2020

Event Type  Injury  

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 could not be completed as original lot information could not be obtained.

Event Description

A complaint was initiated for a patient who underwent a hip revision surgery on (b)(6) 2020.The original surgery date is unknown.Reason for revision is required head size change.During this revision, the original insert and cocr head was exchanged.

• Brand Name: OMNI HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, HEMI
• 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 ; 4486664
• MDR Report Key: 10325968
• MDR Text Key: 202727661
• Report Number: 1226188-2020-00127
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR