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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) SUPER FINISH FEMORAL; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE(R) SUPER FINISH FEMORAL; HIP COMPONENT Back to Search Results
Catalog Number 3803-1046
Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Toxicity (2333); Reaction (2414); Fluid Discharge (2686); Test Result (2695)
Event Date 01/21/2014
Event Type  Injury  
Event Description
Allegedly , patient was revised due to mom complications: hip pain; elevated serum cobalt and chromium ion levels; elevated metal ion levels; metallosis and a fluid collection: right.
 
Manufacturer Narrative
This is the same event as 3010536692-2015-01210.
 
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Brand Name
CONSERVE(R) 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
901867-477
MDR Report Key4803628
MDR Text Key16559565
Report Number3010536692-2015-01211
Device Sequence Number1
Product Code KXA
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 04/28/2015
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 Number3803-1046
Device Lot Number11413509520
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date01/21/2014
Event Location Hospital
Initial Date Manufacturer Received 04/28/2015
Initial Date FDA Received05/28/2015
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 Age77 YR
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