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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION BIOFOAM PRESSFIT KEEL; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTION BIOFOAM PRESSFIT KEEL; KNEE COMPONENT Back to Search Results
Model Number ETPK1556
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Event was reported under 3010536692-2020-00792.This is an additional component associated to the event.
 
Event or Problem Description
Allegedly, there was a fractured of tibial base plate on the right knee.Components not revised: -evolution femoral efsrp6pr, lot# 1750136.-advance metal back patella kpon35mb, lot# 1743601.
 
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Brand Name
EVOLUTION BIOFOAM PRESSFIT KEEL
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11275671
Report Number3010536692-2021-00059
Device Sequence Number17018771
Product Code MBH
UDI-Device IdentifierM684ETPK15561
UDI-PublicM684ETPK15561
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/03/2021
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 Health Professional
Device Model NumberETPK1556
Device Catalogue NumberETPK1556
Device Lot Number1747669
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/07/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/07/2020
Initial Report FDA Received Date02/03/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age51 YR
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