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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP CS INSERT SIZE 6 STANDARD 12MM LEFT; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTION® MP CS INSERT SIZE 6 STANDARD 12MM LEFT; KNEE COMPONENT Back to Search Results
Model Number EIS6S12L
Medical Device Problem Code Unstable (1667)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Revision insert change left tkr-poly exchange.Patient loose in extension-lateral compartment.Patella lift off-patella implant removed-fracture observed post removal 12mm left cs insert removed, 35mm patella removed.14mm left cs implanted.No patella replaced and no fixation of patella.Knee stable in flexion and extension.
 
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Brand Name
EVOLUTION® MP CS INSERT SIZE 6 STANDARD 12MM LEFT
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8804292
Report Number3010536692-2019-00907
Device Sequence Number327562
Product Code HRY
UDI-Device IdentifierM684EIS6S12L1
UDI-PublicM684EIS6S12L1
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) 06/23/2019
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 NumberEIS6S12L
Device Catalogue NumberEIS6S12L
Device Lot Number1702822
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/23/2019
Initial Date Received by Manufacturer 06/23/2019
Supplement Date Received by Manufacturer06/23/2019
Initial Report FDA Received Date07/18/2019
Supplement Report FDA Received Date10/31/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age56 YR
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