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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 3 LEFT 1; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 3 LEFT 1; KNEE COMPONENT Back to Search Results
Model Number KIMP310L
Medical Device Problem Code Difficult to Insert (1316)
Health Effect - Clinical Code No Information (3190)
Date of Event 02/27/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
 
Event or Problem Description
Allegedly, when positioning the insert, it would not seat into the tibial base and this generated a tibial base deformity.
 
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Brand Name
ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 3 LEFT 1
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9873399
Report Number3010536692-2020-00279
Device Sequence Number2877862
Product Code JWH
UDI-Device IdentifierM684KIMP310L1
UDI-PublicM684KIMP310L1
Combination Product (Y/N)N
Initial Reporter CountryCO
PMA/510(K) Number
K972770
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 07/09/2020
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
Operator of Device Other
Device Model NumberKIMP310L
Device Catalogue NumberKIMP310L
Device Lot Number1793564
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/02/2020
Initial Date Received by Manufacturer 03/02/2020
Supplement Date Received by Manufacturer03/02/2020
Initial Report FDA Received Date03/24/2020
Supplement Report FDA Received Date07/09/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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