MAUDE Adverse Event Report: OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTESIS, HIP, SEMICONSTRAINED

Model Number	H3-54099
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2020
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) 2020.The original surgery date is (b)(6) 2019.Reason for revision is change in patient anatomy.During this revision, the original insert and cocr head was exchanged.

• Brand Name: OMNI HIP SYSTEM
• Common Device Name: PROSTESIS, HIP, SEMICONSTRAINED
• Manufacturer (Section D): OMNILIFE SCIENCE, INC.; 480 paramount drive; raynham, ma
• MDR Report Key: 10445397
• Report Number: 1226188-2020-00151
• Device Sequence Number: 4044658
• Product Code: LZO
• UDI-Device Identifier: 00841690119340
• UDI-Public: 00841690119340
• 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): 08/24/2020

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: H3-54099
• Device Catalogue Number: H3-54099
• Device Lot Number: 32286
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/24/2020
• 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: 69 YR