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

Catalog Number 302800

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/15/2020

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 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) 2020.The original surgery date is (b)(6) 2019.The reason for revision is reported peri-prosthetic fracture.During the revision, the acetabular insert and femoral head was removed and replaced with a new devices.

• 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
• MDR Report Key: 10744941
• MDR Text Key: 213370370
• Report Number: 1226188-2020-00179
• Device Sequence Number: 1
• Product Code: KWY
• 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: 10/27/2020

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: 28777
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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: 88 YR