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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, SEMICONTRAINED
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OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, SEMICONTRAINED Back to Search Results
Model Number 304035
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 08/22/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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) 2020.The original surgery date is (b)(6) 2015.The reason for revision is reported disassociation.During the revision, components were removed and replaced with non-omni devices.
 
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Brand Name
OMNI HIP SYSTEM
Common Device Name
PROSTHESIS, HIP, SEMICONTRAINED
Manufacturer (Section D)
OMNILIFE SCIENCE, INC.
480 paramount drive
raynham, ma
MDR Report Key10467536
Report Number1226188-2020-00155
Device Sequence Number14203554
Product Code LPH
UDI-Device Identifier00841690103233
UDI-Public00841690103233
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K100555
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/28/2020
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 Date04/30/2019
Device Model Number304035
Device Catalogue Number304035
Device Lot Number17224
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/22/2020
Initial Report FDA Received Date08/28/2020
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 Age85 YR
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