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

Catalog Number	HC-00045
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A complaint was initiated for a patient who underwent a hip revision surgery on (b)(6) 2024.The original surgery occurred on (b)(6) 2017.The reason for revision is reported patient pain.During the revision, the original stem, and femoral head were removed.
Additional 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.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.
Event or Problem Description
According to the patient's legal representative the patient underwent a left total hip arthroplasty (tha) on (b)(6)2017"[lm1]".During the surgery, the following tha devices were implanted: omni k1 porus femoral stem size 4 latr (ref: (b)(6) lot: 24813), omni femoral cocr femoral head size 28mm + 0mm (ref: 302800 lot: 26609) and another manufactures "[lm2]" acetabular cup and liner.In (b)(6) 2024 (exact date unknown) a revision tha was recommended by a different surgeon.The records obtained to date do not detail the reason for the revision procedure.On (b)(6) 2024, the surgeon performed an extended trochanteric osteotomy to remove both the omni and other manufacturer's hip devices; a revision tha was then performed with a different manufacturer's devices.The patient's legal representative alleges that upon inspection of the omni and other manufacturer's devices explanted on (b)(6) 2024, the devices were subject to excessive wear and related damage.
Additional 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.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.Report update to correct reason for revision , from patient pain to wear of implants.

• Brand Name: OMNI HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): OMNILIFE SCIENCE; 480 paramount dr; raynham MA 02767
• Manufacturer (Section G): OMNILIFE SCIENCE; 480 paramount dr; raynham MA 02767
• Manufacturer Contact: jamie demedeiros ; 480 paramount dr; raynham, MA 02767
• MDR Report Key: 24579798
• Report Number: 1226188-2026-00013
• Device Sequence Number: 9323666
• Product Code: LPH
• UDI-Device Identifier: 00841690100089
• UDI-Public: 00841690100089
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K060072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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 Expiration Date: 10/31/2021
• Device Catalogue Number: HC-00045
• Device Lot Number: 24813
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REF: (B)(6). LOT NUMBER: 26609.; REF: 302800LOT NUMBER: 26609; REF: 302800LOT NUMBER: 26609
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown