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

Model Number	HC-00050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
There was a periprosthetic fracture, and we had to remove the k-1 stem and head and go back in with the k2 mid stem.
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.A 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.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.

• Brand Name: OMNI HIP
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): OMNILIFE SCIENCE INC.; 480 paramount drive; raynham MA 02767
• Manufacturer (Section G): OMNILIFE SCIENCE INC.; 480 paramount drive; raynham MA 02767
• Manufacturer Contact: jamie demedeiros ; 480 paramount drive; raynham, MA 02767
• MDR Report Key: 16474161
• Report Number: 1226188-2023-00088
• Device Sequence Number: 12680440
• Product Code: LPH
• UDI-Device Identifier: 00841690100096
• UDI-Public: 00841690100096
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K060072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 03/03/2023

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: HC-00050
• Device Catalogue Number: HC-00050
• Device Lot Number: 34383
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/02/2023
• Date Device Manufactured: 08/15/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female