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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, HEMI-, FEMORAL
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OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, HEMI-, FEMORAL Back to Search Results
Catalog Number HC-22004
Health Effect - Clinical Code Autoimmune Reaction (1733)
Date of Event 10/05/2016
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
The complaint involved a patient who underwent a hip revision surgery on (b)(6) 2016.The original surgery is dated (b)(6) 2011.The revision surgery occurred because of elevated cobalt chromium levels.During the revision, the original non-omni acetabular cup, acetabular liner and various screws, along with the omni femoral stem, femoral head and anteverted neck were removed.
 
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Brand Name
OMNI HIP SYSTEM
Common Device Name
PROSTHESIS, HIP, HEMI-, FEMORAL
Manufacturer (Section D)
OMNILIFE SCIENCE, INC.
480 paramount drive
raynham MA 02767
MDR Report Key6675328
Report Number1226188-2017-00062
Device Sequence Number13946328
Product Code KWY
UDI-Device Identifier00841690115939
UDI-Public00841690115939
Combination Product (Y/N)N
PMA/510(K) Number
K111193
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/01/2017
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 Date09/30/2016
Device Catalogue NumberHC-22004
Device Lot Number9875
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/01/2017
Initial Report FDA Received Date06/28/2017
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 Age38 YR
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