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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-NP30
Device Problem Sticking (1597)
Patient Problem No Code Available (3191)
Event Date 10/22/2014
Event Type  Injury  
Event Description
Allegedly, the patient was revise due to stiffness (right).Revision njr index no: (b)(4).
 
Manufacturer Narrative
This 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 3010536692-2015-00870, -00872.
 
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
901867-441
MDR Report Key4757641
MDR Text Key5783094
Report Number3010536692-2015-00871
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
Type of Report Initial,Followup
Report Date 04/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberKTCC-NP30
Device Lot Number1510245
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date10/22/2014
Event Location Hospital
Date Manufacturer Received07/08/2015
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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