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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EVOLUTION® REV TIB BASE NONPORSIZE 6 STANDARD RIG; KNEE COMPONENT
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EVOLUTION® REV TIB BASE NONPORSIZE 6 STANDARD RIG; KNEE COMPONENT Back to Search Results
Model Number ETRKN6SR
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Unspecified Infection (1930); Osteolysis (2377)
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 aseptic loosening tibia|infection|lysis tibia.Srnjr number: (b)(4).Side: r.Gender: f.
 
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Brand Name
EVOLUTION® REV TIB BASE NONPORSIZE 6 STANDARD RIG
Common Device Name
KNEE COMPONENT
Manufacturer Contact
rachael wise
microport orthopedics inc. 567
arlington, TN 38002
MDR Report Key19622778
Report Number3010536692-2024-00381
Device Sequence Number6335062
Product Code JWH
UDI-Device IdentifierM684ETRKN6SR1
UDI-PublicM684ETRKN6SR1
Combination Product (Y/N)N
Initial Reporter CountryUK
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2023
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Company Representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/30/2025
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 NumberETRKN6SR
Device Catalogue NumberETRKN6SR
Device Lot Number1805527
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date06/27/2024
Supplement Report FDA Received Date10/30/2025
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexFemale
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