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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 4 RIGHT; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 4 RIGHT; KNEE COMPONENT Back to Search Results
Model Number KIMP417R
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
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly, poly swap-cultures taken- pt has possible infection-redness in right leg along with smelling.
 
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Brand Name
ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 4 RIGHT
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9142777
Report Number3010536692-2019-01064
Device Sequence Number3046990
Product Code JWH
UDI-Device IdentifierM684KIMP417R1
UDI-PublicM684KIMP417R1
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K972770
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/03/2020
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 NumberKIMP417R
Device Catalogue NumberKIMP417R
Device Lot Number06347637
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/06/2019
Initial Date Received by Manufacturer 09/06/2019
Supplement Date Received by Manufacturer09/06/2019
Initial Report FDA Received Date10/01/2019
Supplement Report FDA Received Date02/03/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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