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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 5 LEFT 1; KNEE COMPONENT

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MICROPORT ORTHOPEDICS INC. ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 5 LEFT 1; KNEE COMPONENT Back to Search Results
Model Number KIMP514L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Not Applicable (3189)
Event Type  Injury  
Event Description
Allegedly, patella resurfacing and poly swap , same thickness poly was put back in.Left knee components not revised: advance® primary femoral size 5 left porous product id : kftcpc5l lot number: 01333763, advance® ii spiked tibial base porous coated size 5+ product id: ktsppc51 lot number : 09227685, advance® modular keel sz 5/6 product id: spkt0024 lot number: 01334085.
 
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Brand Name
ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 5 LEFT 1
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 Key10851708
MDR Text Key216610470
Report Number3010536692-2020-00698
Device Sequence Number1
Product Code JWH
UDI-Device IdentifierM684KIMP514L1
UDI-PublicM684KIMP514L1
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 distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 11/17/2020
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 Health Professional
Device Model NumberKIMP514L
Device Catalogue NumberKIMP514L
Device Lot Number120A132553
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/03/2020
Initial Date Manufacturer Received 11/03/2020
Initial Date FDA Received11/17/2020
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) Other;
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