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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-CONTRAINED
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OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONTRAINED Back to Search Results
Catalog Number HC-22001
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 01/12/2018
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) 2018.The original surgery is dated (b)(6) 2010.The reason for revision is reported patient pain.During the revision, the original omni hip stem and neck were removed and replaced.
 
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Brand Name
OMNI HIP SYSTEM
Common Device Name
PROSTHESIS, HIP, SEMI-CONTRAINED
Manufacturer (Section D)
OMNILIFE SCIENCE, INC.
480 paramount drive
raynham MA 02767
MDR Report Key9582465
Report Number1226188-2020-00009
Device Sequence Number3244800
Product Code LPH
UDI-Device Identifier00841690115908
UDI-Public00841690115908
Combination Product (Y/N)N
PMA/510(K) Number
K090845
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/13/2020
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 Date05/31/2015
Device Catalogue NumberHC-22001
Device Lot Number6702
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/23/2019
Initial Report FDA Received Date01/13/2020
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;
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