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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 14MM RIGH; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 4 STANDARD 14MM RIGH; KNEE COMPONENT Back to Search Results
Model Number EIS4S14R
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 evaluated.
 
Event or Problem Description
Allegedly, patient was revised due to infection, the liner was wash out and exchange.(b)(6).Products not revised: evolution mp keeled tibial base product id: (b)(4) lot id: 1537440; evolution mp cs/cr femoral component product id: (b)(4) lot id: 1526818; advance onlay all-polly patella product id: (b)(6) lot id: 1539628.
 
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Brand Name
EVOLUTION MP CS INSERT SIZE 4 STANDARD 14MM RIGH
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9820337
Report Number3010536692-2020-00220
Device Sequence Number3069404
Product Code HRY
UDI-Device IdentifierM684EIS4S14R1
UDI-PublicM684EIS4S14R1
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K093552
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2020
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/29/2020
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 NumberEIS4S14R
Device Catalogue NumberEIS4S14R
Device Lot Number0511354154
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/20/2020
Initial Date Received by Manufacturer 02/20/2020
Supplement Date Received by Manufacturer02/20/2020
Initial Report FDA Received Date03/11/2020
Supplement Report FDA Received Date09/29/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age82 YR
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