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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION REVISION STEMMED CS FEMUR; FEMORAL COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTION REVISION STEMMED CS FEMUR; FEMORAL COMPONENT Back to Search Results
Model Number EFXSNP6R
Health Effect - Clinical Codes Bone Fracture(s) (1870); Unspecified Infection (1930)
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
EVOLUTION REVISION STEMMED CS FEMUR
Common Device Name
FEMORAL COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11340273
Report Number3010536692-2021-00087
Device Sequence Number11606252
Product Code JWH
UDI-Device IdentifierM684EFXSNP6R1
UDI-PublicM684EFXSNP6R1
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
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 NumberEFXSNP6R
Device Catalogue NumberEFXSNP6R
Device Lot Number1597138
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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