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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, HEMI
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OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, HEMI Back to Search Results
Catalog Number 302800
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Hip Fracture (2349)
Date of Event 06/11/2019
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
A complaint was initiated for a patient who underwent a hip revision surgery on (b)(6) 2019.The original surgery is dated (b)(6) 2019.The reason for revision is reported peri-prosthetic fracture.During the revision, the omni distributed stem and cup were removed and replaced.The original omni femoral head was removed and replaced.
 
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Brand Name
OMNI HIP SYSTEM
Common Device Name
PROSTHESIS, HIP, HEMI
Manufacturer (Section D)
OMNILIFE SCIENCE, INC.
480 paramount drive
raynham MA 02767
MDR Report Key8759335
Report Number1226188-2019-00108
Device Sequence Number1342188
Product Code KWY
UDI-Device Identifier00841690100355
UDI-Public00841690100355
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K082468
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/03/2019
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 Catalogue Number302800
Device Lot Number29493
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/11/2019
Initial Report FDA Received Date07/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age59 YR
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