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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE(R) II COCR TIBIAL BASE; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE(R) II COCR TIBIAL BASE; KNEE COMPONENT Back to Search Results
Catalog Number KTCC-NP50
Device Problem Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 04/07/2015
Event Type  Injury  
Manufacturer Narrative
This is report will be updated when investigation is complete.Trends will be evaluated.This event occurred in the (b)(6).This is the same event as 3010536692-2015-01529, -01531.
 
Event Description
Allegedly revised due to malalignment (left).Revision njr index no: (b)(4).
 
Manufacturer Narrative
The complaint database was reviewed and analysis showed no trend for item/lot.
 
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Brand Name
ADVANCE(R) II COCR TIBIAL BASE
Type of Device
KNEE 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
9018674771
MDR Report Key5001718
MDR Text Key22937366
Report Number3010536692-2015-01530
Device Sequence Number1
Product Code HRY
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
Report Date 07/13/2015
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 Other
Device Catalogue NumberKTCC-NP50
Device Lot Number0311324963
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date04/07/2015
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/13/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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