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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II REVISION CCK INSERT SIZE 4 STANDARD 10; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE® II REVISION CCK INSERT SIZE 4 STANDARD 10; KNEE COMPONENT Back to Search Results
Model Number KIRV410S
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Investigation completed.Evaluation codes added.
 
Event or Problem Description
Allegedly, patient was revised due to infection.Components not revised: advance revision femoral size 4 right nonporous product id: kfccnp4r lot id: 38574513.Advance onlay all poly patella 32mm single peg product id: kpon32st lot id:45217834.Revision njr number: 1791492.Side:r.Primary asa: p2 - mild disease not incapacitating.
 
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Brand Name
ADVANCE® II REVISION CCK INSERT SIZE 4 STANDARD 10
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10206395
Report Number3010536692-2020-00448
Device Sequence Number935661
Product Code JWH
UDI-Device IdentifierM684KIRV410S1
UDI-PublicM684KIRV410S1
Combination Product (Y/N)N
Initial Reporter CountryGB
PMA/510(K) Number
K990030
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2013
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/29/2020
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 NumberKIRV410S
Device Catalogue NumberKIRV410S
Device Lot Number17394856
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 Date06/29/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
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