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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) PLUS SUPER FINISH FEMORAL; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE(R) PLUS SUPER FINISH FEMORAL; HIP COMPONENT Back to Search Results
Catalog Number 3802-1048
Device Problem Metal Shedding Debris (1804)
Patient Problems Pain (1994); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
Event Date 06/10/2005
Event Type  Injury  
Event Description
Allegedly, patient revised due to pain, difficulty walking, sitting, standing, bending; discolored synovium; popping, grinding; elevated cobalt and & chromium levels; revision.
 
Manufacturer Narrative
This is the same event as 3010536692-2015-00539.
 
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Brand Name
CONSERVE(R) PLUS SUPER FINISH FEMORAL
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 Key4606229
MDR Text Key15222936
Report Number3010536692-2015-00540
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 02/19/2015
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 Physician
Device Catalogue Number3802-1048
Device Lot Number021A135087
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date06/10/2005
Event Location Hospital
Initial Date Manufacturer Received 02/19/2015
Initial Date FDA Received03/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age39 YR
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