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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 RIGHT; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 5 RIGHT; KNEE COMPONENT Back to Search Results
Model Number KIMP510R
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Loss of Range of Motion (2032)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, patient was revised due to stiffness.Components not revised: advance ii cocr tibia base nonporous sz 5 standard product id: ktccnp50 lot id: 087465508.Advance onlay all poly patella 38mm tripeg product id: kpontp38 product id: 046332811.Revision njr number: 1058353.Side: r.Primary asa: p3 - incapacitating systemic disease.
 
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Brand Name
ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 5 RIGHT
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10184526
Report Number3010536692-2020-00404
Device Sequence Number835870
Product Code JWH
UDI-Device IdentifierM684KIMP510R1
UDI-PublicM684KIMP510R1
Combination Product (Y/N)N
Initial Reporter CountryGB
PMA/510(K) Number
K972770
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Device Explanted Year2008
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/23/2020
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 Health Professional
Device Model NumberKIMP510R
Device Catalogue NumberKIMP510R
Device Lot Number047424127
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/08/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/08/2020
Initial Report FDA Received Date06/23/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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