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

Model Number 302835

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 09/25/2021

Event Type  Injury  

Manufacturer Narrative

Even though the failure reported was for fracture and not for a possible implant defect 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.

Event Description

A complaint was initiated for a patient who underwent a hip revision surgery on (b)(6) 2021.The original surgery date is (b)(6) 2021.The reason for revision is reported patient fall that resulted in peri-prosthetic fracture of an omni distributed stem.During the revision, the stem, acetabular insert and femoral head were removed and replaced with new devices.

• Brand Name: OMNI HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL,
• Manufacturer (Section D): OMNI LIFE SCIECE, INC.; 480 paramount drive; raynham MA 02767
• Manufacturer (Section G): OMNI LIFE SCIECE, INC.; 480 paramount drive; raynham MA 02767
• Manufacturer Contact: jamie demedeiros ; 480 paramont dr.; raynham, MA 02767 ; 7742261848
• MDR Report Key: 12579561
• MDR Text Key: 274909021
• Report Number: 1226188-2021-00126
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00841690100386
• UDI-Public: 00841690100386
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 302835
• Device Catalogue Number: 302835
• Device Lot Number: 38060
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• Is the Device Single Use?: No
• 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: 78 YR