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

Model Number	302899
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The complaint involved a patient who underwent a hip revision surgery on (b)(6) 2020.The original surgery is dated (b)(6) 2020.The revision surgery occurred because of a reported dislocation leading to disassociation of the head from the bipolar.During the revision, the original omni femoral head and bipolar head were removed and replaced with a new head, cup and insert.

• Brand Name: OMNI HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL
• Manufacturer (Section D): OMNILIFE SCIENCE INC.; 480 paramount dr.; raynham, ma
• MDR Report Key: 9954397
• Report Number: 1226188-2020-00070
• Device Sequence Number: 2718262
• Product Code: KWY
• UDI-Device Identifier: 00841690100393
• UDI-Public: 00841690100393
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 04/13/2020

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 Expiration Date: 04/01/2024
• Device Model Number: 302899
• Device Catalogue Number: 302899
• Device Lot Number: 299441
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/13/2020
• 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: 77 YR