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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 3; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE® BIOFOAM® TIBIA BASE W/O SCREWHOLES SIZE 3; KNEE COMPONENT Back to Search Results
Model Number KTSLFM31
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly tibial pain is what the patient was experiencing and revised due to.The poly was removed along with the tib base and keel.A new tib base was implanted along with a 2.5 mm augments and a poly.(right).
 
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Brand Name
ADVANCE® BIOFOAM® TIBIA BASE W/O SCREWHOLES SIZE 3
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8759495
Report Number3010536692-2019-00899
Device Sequence Number13873139
Product Code MBH
UDI-Device IdentifierM684KTSLFM311
UDI-PublicM684KTSLFM311
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 Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/03/2019
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 NumberKTSLFM31
Device Catalogue NumberKTSLFM31
Device Lot Number1678432
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/07/2019
Initial Date Received by Manufacturer 06/07/2019
Supplement Date Received by Manufacturer06/07/2019
Initial Report FDA Received Date07/03/2019
Supplement Report FDA Received Date09/03/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age66 YR
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