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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 12MM RIGH; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 4 STANDARD 12MM RIGH; KNEE COMPONENT Back to Search Results
Model Number EIS4S12R
Medical Device Problem Codes Unstable (1667); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly, the liner was increased from 12mm to 14mm due to anterior knee pain.The action taken was to resurface the patella.The increased poly size to sz4 14mm was to address slight ligament laxity in flexion over time.
 
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Brand Name
EVOLUTION® MP? CS INSERT SIZE 4 STANDARD 12MM RIGH
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9119751
Report Number3010536692-2019-01050
Device Sequence Number2307924
Product Code HRY
UDI-Device IdentifierM684EIS4S12R1
UDI-PublicM684EIS4S12R1
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 Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/03/2020
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 NumberEIS4S12R
Device Catalogue NumberEIS4S12R
Device Lot Number1667258
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/26/2019
Initial Date Received by Manufacturer 08/26/2019
Supplement Date Received by Manufacturer08/26/2019
Initial Report FDA Received Date09/25/2019
Supplement Report FDA Received Date02/03/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age83 YR
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