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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 4 STANDARD 10MM LEFT; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 4 STANDARD 10MM LEFT; KNEE COMPONENT Back to Search Results
Model Number EIS4S10L
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 12/04/2019
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 due to infection.The liner was not replaced, simply washed out only.(b)(6).
 
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Brand Name
EVOLUTION MP CS INSERT SIZE 4 STANDARD 10MM LEFT
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9544778
Report Number3010536692-2020-00012
Device Sequence Number2375589
Product Code HRY
UDI-Device IdentifierM684EIS4S10L1
UDI-PublicM684EIS4S10L1
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K093552
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 08/27/2020
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 NumberEIS4S10L
Device Catalogue NumberEIS4S10L
Device Lot Number1789770
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/08/2019
Initial Date Received by Manufacturer 12/08/2019
Supplement Date Received by Manufacturer12/08/2019
Initial Report FDA Received Date01/03/2020
Supplement Report FDA Received Date08/27/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age69 YR
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