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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 10MM LEFT; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 10MM LEFT; KNEE COMPONENT Back to Search Results
Model Number EIS5S10L
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code 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 evaluate.
 
Event or Problem Description
Allegedly, patient was revised due to infection; underwent washout and liner exchange only.(b)(6).
 
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Brand Name
EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 10MM LEFT
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9904171
Report Number3010536692-2020-00298
Device Sequence Number19008254
Product Code HRY
UDI-Device IdentifierM684EIS5S10L1
UDI-PublicM684EIS5S10L1
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K093552
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/11/2020
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 NumberEIS5S10L
Device Catalogue NumberEIS5S10L
Device Lot Number1541882
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/10/2020
Initial Date Received by Manufacturer 03/10/2020
Supplement Date Received by Manufacturer03/10/2020
Initial Report FDA Received Date03/31/2020
Supplement Report FDA Received Date06/11/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age78 YR
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