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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE(R) TOT COND MEDIAL PIVOT TIBIAL INSERT; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE(R) TOT COND MEDIAL PIVOT TIBIAL INSERT; KNEE COMPONENT Back to Search Results
Catalog Number KITC-310R
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Reaction (2414)
Event Date 11/12/2013
Event Type  Injury  
Event Description
Allegedly the patient was having pain; knee contained metallosis; insert removed; metal pegs on tibial insert were worn down (right).
 
Manufacturer Narrative
The investigation is not complete.The trends will be evaluated.This report will be updated when the investigation is complete.
 
Manufacturer Narrative
The complaint database was reviewed and analysis showed no trend for item/lot.
 
Manufacturer Narrative
Determined lot number.Updated with lot number.
 
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Brand Name
ADVANCE(R) TOT COND MEDIAL PIVOT TIBIAL INSERT
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 Key3654511
MDR Text Key4315240
Report Number3010536692-2014-00382
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972770
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 02/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberKITC-310R
Device Lot Number048A083683
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2014
Is the Reporter a Health Professional? No
Distributor Facility Aware Date11/12/2013
Event Location Hospital
Date Manufacturer Received05/09/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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