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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) MODULAR FEMORAL NECK; HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. PROFEMUR(R) MODULAR FEMORAL NECK; HIP COMPONENT Back to Search Results
Catalog Number PHA0-12XX
Device Problem Insufficient Information (3190)
Patient Problem Hematoma (1884)
Event Date 04/23/2014
Event Type  Injury  
Event Description
Allegedly revised for a hematoma.1st plan of procedure was to remove conserve cup and modular neck.Replace with new modular neck and head.Use competitor cup.Procedure changed to remove entire stem because modular neck would not separate.
 
Manufacturer Narrative
The investigation is not complete.Trends will be evaluated.This report will be updated when the investigation is complete.This is the same event as 3010536692-2014-00725, 00726, 00727.
 
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Brand Name
PROFEMUR(R) MODULAR FEMORAL NECK
Type of Device
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington, TN 38002
901867-441
MDR Report Key3783859
MDR Text Key4442047
Report Number3010536692-2014-00724
Device Sequence Number1
Product Code LWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/24/2014
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
Device Operator Other
Device Catalogue NumberPHA0-12XX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date04/23/2014
Event Location Hospital
Initial Date Manufacturer Received 07/25/2014
Initial Date FDA Received05/01/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/07/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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