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

Catalog Number HC-24002-HA

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 12/11/2019

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 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) 2014.The reason for revision is reported patient pain.During the revision, the original omni stem and femoral head were removed and replaced with non-omni product.

• 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: 9548485
• MDR Text Key: 174408581
• Report Number: 1226188-2019-00219
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00841690125976
• UDI-Public: 00841690125976
• Combination Product (y/n): N
• PMA/PMN Number: K133381
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: HC-24002-HA
• Device Lot Number: 16871
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• 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: 68 YR