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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 400000
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 10/15/2020
Type of Reportable Event Malfunction
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 surgery.During the surgery an apical plug was used on an implant size it is not recommended for.
 
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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 02767
MDR Report Key10760237
Report Number1226188-2020-00189
Device Sequence Number14290053
Product Code LPH
UDI-Device Identifier00841690102410
UDI-Public00841690102410
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K031110
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/31/2020
Device Model Number400000
Device Catalogue Number400000
Device Lot Number21353
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/19/2020
Initial Report FDA Received Date10/30/2020
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;
Patient Age70 YR
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