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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMNILIFE SCIENCE INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED
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OMNILIFE SCIENCE INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED Back to Search Results
Model Number HC-21003-HA
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 07/24/2019
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) 2014.The revision surgery occurred because of reported patient pain.During the revision all omni product was removed and replaced with non-omni product.
 
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Brand Name
OMNI HIP SYSTEM
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED
Manufacturer (Section D)
OMNILIFE SCIENCE INC.
480 paramount dr.
raynham, ma
MDR Report Key9812451
Report Number1226188-2020-00057
Device Sequence Number10915088
Product Code LPH
UDI-Device Identifier00841690115816
UDI-Public00841690115816
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090845
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/10/2020
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 Date12/01/2017
Device Model NumberHC-21003-HA
Device Catalogue NumberHC-21003-HA
Device Lot Number12962
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/05/2020
Initial Report FDA Received Date03/10/2020
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 Age60 YR
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