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

Model Number 302899

Device Problem Insufficient Information (3190)

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

Event Date 04/10/2020

Event Type  Injury  

Manufacturer Narrative

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

The complaint involved a patient who underwent a hip revision surgery on (b)(6) 2020.The original surgery is dated (b)(6) 2020.The revision surgery occurred because of a reported dislocation leading to disassociation of the head from the bipolar.During the revision, the original omni femoral head and bipolar head were removed and replaced with a new head, cup and insert.

• Brand Name: OMNI HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL
• Manufacturer (Section D): OMNILIFE SCIENCE INC.; 480 paramount dr.; raynham, ma
• Manufacturer (Section G): OMNILIFE SCIENCE INC.; 480 paramount dr.; raynham, ma
• Manufacturer Contact: diane moore ; 480 paramount dr.; raynham, ma ; 8242444
• MDR Report Key: 9954397
• MDR Text Key: 190773848
• Report Number: 1226188-2020-00070
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00841690100393
• UDI-Public: 00841690100393
• 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: 04/13/2020

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 Expiration Date: 04/01/2024
• Device Model Number: 302899
• Device Catalogue Number: 302899
• Device Lot Number: 299441
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 04/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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: 77 YR