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

Model Number	H3-53604
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/28/2021
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) 2021.The original surgery is dated on (b)(6) 2020.The reason for revision is reported dislocation.During the surgery, original femoral head and modular neck with bolt were replaced for new components.
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.According to the intake form, the products are not available for return and evaluation.Even though the failure reported was for dislocation 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 is dated on (b)(6) 2020.The reason for revision is reported dislocation.During the surgery, original femoral head and modular neck with bolt were replaced for new components.
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.According to the intake form, the products are not available for return and evaluation.Even though the failure reported was for dislocation 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.

• Brand Name: OMNI HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• 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: 13335051
• Report Number: 1226188-2022-00002
• Device Sequence Number: 4064581
• Product Code: LZO
• UDI-Device Identifier: 00841690119289
• UDI-Public: 00841690119289
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2022

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: H3-53604
• Device Catalogue Number: H3-53604
• Device Lot Number: 34058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown