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

Model Number	302835
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/25/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL,
• Manufacturer (Section D): OMNI LIFE SCIECE, INC.; 480 paramount drive; raynham MA 02767
• MDR Report Key: 12579561
• Report Number: 1226188-2021-00126
• Device Sequence Number: 16445177
• Product Code: KWY
• UDI-Device Identifier: 00841690100386
• UDI-Public: 00841690100386
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: 302835
• Device Catalogue Number: 302835
• Device Lot Number: 38060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2021
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR