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

Model Number	H3-53204
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional 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.Even though the failure reported was for malalignment 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) 2020.The original surgery is dated (b)(6) 2019.The reason for revision is reported malalignment.During the revision, the original ceramic femoral head was removed and replaced for a new component.

• Brand Name: OMNI HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): OMNILIFE SCIENCE, INC.; 480 paramount drive; raynham, ma
• MDR Report Key: 10425146
• Report Number: 1226188-2020-00142
• Device Sequence Number: 11444993
• Product Code: LZO
• UDI-Device Identifier: 00841690119241
• UDI-Public: 00841690119241
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

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
• Operator of Device: Health Professional
• Device Model Number: H3-53204
• Device Catalogue Number: H3-53204
• Device Lot Number: 31321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/19/2020
• 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: 50 YR