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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 LEFT 1; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 4 LEFT 1; KNEE COMPONENT Back to Search Results
Model Number KIMP417L
Medical Device Problem Codes Unstable (1667); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
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 unstable knee and the insert was exchanged.
 
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Brand Name
ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 4 LEFT 1
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9821164
Report Number3010536692-2020-00221
Device Sequence Number3087195
Product Code JWH
UDI-Device IdentifierM684KIMP417L1
UDI-PublicM684KIMP417L1
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K972770
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/21/2020
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 NumberKIMP417L
Device Catalogue NumberKIMP417L
Device Lot NumberA106377
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/14/2020
Initial Date Received by Manufacturer 02/14/2020
Supplement Date Received by Manufacturer02/14/2020
Initial Report FDA Received Date03/11/2020
Supplement Report FDA Received Date09/21/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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