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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP ADAPTIVE CS INSER IMPLANT SZ 6/4 RIGH; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTIONMP ADAPTIVE CS INSER IMPLANT SZ 6/4 RIGH; KNEE COMPONENT Back to Search Results
Model Number EAI6412R
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
EVOLUTIONMP ADAPTIVE CS INSER IMPLANT SZ 6/4 RIGH
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11340310
Report Number3010536692-2021-00088
Device Sequence Number19676236
Product Code HRY
UDI-Device IdentifierM684EAI6412R1
UDI-PublicM684EAI6412R1
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K113325
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 NumberEAI6412R
Device Catalogue NumberEAI6412R
Device Lot Number1413275
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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