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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE CANAL FILLING STEM EXTENSION 18MM X 100MM; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE CANAL FILLING STEM EXTENSION 18MM X 100MM; KNEE COMPONENT Back to Search Results
Model Number KSP17100
Health Effect - Clinical Codes Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
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 on (b)(6) 2018 due to prosthetic joint infection with nonunion of periprosthetic femur fracture.Femoral and tibial components, patella replaced with non-mpo implants by different surgeon.(right knee).
 
Additional Manufacturer Narrative
Included adverse event problem codes.
 
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Brand Name
ADVANCE CANAL FILLING STEM EXTENSION 18MM X 100MM
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11340234
Report Number3010536692-2021-00086
Device Sequence Number3373151
Product Code JWH
UDI-Device IdentifierM684KSP171001
UDI-PublicM684KSP171001
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K973524
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
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) 04/14/2021
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 NumberKSP17100
Device Catalogue NumberKSP17100
Device Lot Number0601127748
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/27/2021
Initial Date Received by Manufacturer 01/27/2021
Supplement Date Received by Manufacturer01/27/2021
Initial Report FDA Received Date02/17/2021
Supplement Report FDA Received Date04/14/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age62 YR
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