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

Catalog Number H3-52800

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

Patient Problem Joint Dislocation (2374)

Event Date 04/08/2024

Event Type  Injury  

Event Description

A complaint was initiated for a patient who underwent a hip revision surgery on (b)(6) 2024.The original surgery is dated (b)(6) 2021.The reason for revision is reported dislocation due to patient fall.During the surgery, the original femoral head and liner were removed and replaced with new implants.

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.According to the intake form, the products are not available for return and evaluation.A review of the manufacturing documentation and sterilization documentation for the devices in question was performed.It revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

• Brand Name: OMNI HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): OMNILIFE SCIENCE; 480 paramount drive; raynham MA 02767
• Manufacturer (Section G): OMNILIFE SCIENCE; 480 paramount drive; raynham MA 02767
• Manufacturer Contact: jamie demedeiros ; 480 paramount drive; raynham, MA 02767 ; 5088226030
• MDR Report Key: 19164483
• MDR Text Key: 340835316
• Report Number: 1226188-2024-00164
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00841690119203
• UDI-Public: 00841690119203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101451
• 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: 04/22/2024

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 Expiration Date: 04/30/2022
• Device Catalogue Number: H3-52800
• Device Lot Number: 27214
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2017
• 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: 49 YR
• Patient Sex: Male