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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

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OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM PROSTHESIS, HIP, HEMI Back to Search Results
Catalog Number H3-82847
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/26/2018
Event Type  Injury  
Manufacturer Narrative
The complainant made no indication of any omnilife science device malfunction or deficiency related to the identity, quality, durability, reliability, safety, effectiveness or device performance contributing to the adverse event. 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 Description
The complaint involved a patient who underwent a hip revision surgery on (b)(6) 2018. The original surgery is dated (b)(6) 2018. The revision surgery occurred because of reported bone spur removing the bipolar head. During the revision, the bone spur was removed, the offset of the femoral head was changed and the bipolar head was replaced with a new component of a larger size.
 
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Brand NameOMNI HIP SYSTEM
Type of DevicePROSTHESIS, HIP, HEMI
Manufacturer (Section D)
OMNILIFE SCIENCE, INC.
480 paramount drive
raynham MA 02767
Manufacturer (Section G)
OMNILIFE SCIENCE, INC.
480 paramount drive
raynham MA 02767
Manufacturer Contact
george cipolletti
480 paramount drive
raynham, MA 02767
MDR Report Key8265258
MDR Text Key133704593
Report Number1226188-2019-00001
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100151
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberH3-82847
Device Lot Number30270
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/21/2019 Patient Sequence Number: 1
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