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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE BIOFOAM TIBIA BASE W/O SCREWHOLES SIZE 4; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE BIOFOAM TIBIA BASE W/O SCREWHOLES SIZE 4; KNEE COMPONENT Back to Search Results
Model Number KTSLFM40
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code No Information (3190)
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, looks like the tibial base plate is loosening , patella was spinning and femur could not balance in flexion and extension so femur had to go.Additional information: left knee.
 
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Brand Name
ADVANCE BIOFOAM TIBIA BASE W/O SCREWHOLES SIZE 4
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9842791
Report Number3010536692-2020-00242
Device Sequence Number2856102
Product Code MBH
UDI-Device IdentifierM684KTSLFM401
UDI-PublicM684KTSLFM401
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K063128
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/02/2020
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 NumberKTSLFM40
Device Catalogue NumberKTSLFM40
Device Lot Number1641106
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/26/2020
Initial Date Received by Manufacturer 02/26/2020
Supplement Date Received by Manufacturer02/26/2020
Initial Report FDA Received Date03/17/2020
Supplement Report FDA Received Date10/02/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age73 YR
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