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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
Catalog Number 303200
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Fall (1848)
Date of Event 05/15/2019
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) 2016.The revision surgery occured because of reported patient fall.During the revision, the original femoral cocr head was removed and replaced with a new femoral cocr head.
 
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Brand Name
OMNI HIP SYSTEM
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED
Manufacturer (Section D)
OMNILIFE SCIENCE, INC.
480 paramount drive
raynham MA 02767
MDR Report Key8675247
Report Number1226188-2019-00095
Device Sequence Number2947863
Product Code LPH
UDI-Device Identifier00841690103103
UDI-Public00841690103103
Combination Product (Y/N)N
PMA/510(K) Number
K000788
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/06/2019
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 Expiration Date08/31/2020
Device Catalogue Number303200
Device Lot Number21473
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/16/2019
Initial Report FDA Received Date06/06/2019
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 Age63 YR
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