MAUDE Adverse Event Report: OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Type  Injury  

Event Description

A complaint involved a patient who underwent a hip revision surgery for an alleged intraoperative fracture.

• Brand Name: OMNI HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED
• 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: george cipolletti ; 480 paramount drive; raynham, MA 02767
• MDR Report Key: 7920103
• MDR Text Key: 122105640
• Report Number: 1226188-2018-00153
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• 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: 08/14/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 09/28/2018
• 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