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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 RIGHT; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 3 RIGHT; KNEE COMPONENT Back to Search Results
Model Number KIMP310R
Medical Device Problem Codes Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code Arthritis (1723)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, patient was revised due to aseptic loosening tibia; instability; wear of polyethylene component; progressive arthritis.Revision njr number: (b)(4), side: r, primary asa: p2 - mild disease not incapacitating.Mhra reference no: (b)(4).
 
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Brand Name
ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 3 RIGHT
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10945011
Report Number3010536692-2020-00731
Device Sequence Number642090
Product Code JWH
UDI-Device IdentifierM684KIMP310R1
UDI-PublicM684KIMP310R1
Combination Product (Y/N)N
Initial Reporter CountryGB
PMA/510(K) Number
K972770
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 01/29/2021
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 NumberKIMP310R
Device Catalogue NumberKIMP310R
Device Lot Number118751738
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/16/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/16/2020
Supplement Date Received by Manufacturer11/16/2020
Initial Report FDA Received Date12/04/2020
Supplement Report FDA Received Date01/29/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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