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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+ 12MM LEFT; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 6+ 12MM LEFT; KNEE COMPONENT Back to Search Results
Model Number EIS6P12L
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
Investigation completed.Evaluation codes added.
 
Event Description
Allegedly, patient was revised due to evolution liner infection.Same size insert implanted.(b)(4).
 
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Brand Name
EVOLUTION MP CS INSERT SIZE 6+ 12MM LEFT
Type of Device
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key10271430
MDR Text Key198737501
Report Number3010536692-2020-00487
Device Sequence Number1
Product Code HRY
UDI-Device IdentifierM684EIS6P12L1
UDI-PublicM684EIS6P12L1
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K093552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 07/14/2020
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
Device Operator Health Professional
Device Model NumberEIS6P12L
Device Catalogue NumberEIS6P12L
Device Lot Number15643461584510
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/28/2020
Initial Date Manufacturer Received 06/28/2020
Initial Date FDA Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age74 YR
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