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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 LEFT 1; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 3 LEFT 1; KNEE COMPONENT Back to Search Results
Model Number KIMP314L
Medical Device Problem Code Unstable (1667)
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, possibly loose patella and instability, patella has removed and poly has exchanged for a 17 mm mp size 3.(left knee) original tka surgery: (b)(6) 2008.
 
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Brand Name
ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 3 LEFT 1
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9933427
Report Number3010536692-2020-00327
Device Sequence Number14390851
Product Code JWH
UDI-Device IdentifierM684KIMP314L1
UDI-PublicM684KIMP314L1
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 Year2011
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/16/2020
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 NumberKIMP314L
Device Catalogue NumberKIMP314L
Device Lot Number1001222132
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/16/2020
Initial Date Received by Manufacturer 03/16/2020
Supplement Date Received by Manufacturer03/16/2020
Initial Report FDA Received Date04/07/2020
Supplement Report FDA Received Date06/16/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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