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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) TOTAL HEAD W/BFH; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE(R) TOTAL HEAD W/BFH; HIP COMPONENT Back to Search Results
Catalog Number 3801-4800
Device Problem Failure to Align (2522)
Patient Problem Pain (1994)
Event Date 04/28/2010
Event Type  Injury  
Event Description
Allegedly the patient was revised due to malalignment socket; malalignment stem; other indication for revision; pain (left).Secondary revision njr index no: (b)(4).
 
Manufacturer Narrative
Report will be updated when investigation is complete.Trends will be evaluated.This event occurred in the (b)(6).
 
Manufacturer Narrative
The complaint database was reviewed and analysis showed no trend for item/lot.
 
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Brand Name
CONSERVE(R) TOTAL HEAD W/BFH
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 Key4508485
MDR Text Key16560856
Report Number3010536692-2015-00356
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number3801-4800
Device Lot Number114135090
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date04/28/2010
Event Location Hospital
Date Manufacturer Received04/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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