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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE CANAL FILLING STEM EXTENSION 19MM X 140MM; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE CANAL FILLING STEM EXTENSION 19MM X 140MM; KNEE COMPONENT Back to Search Results
Model Number KSP18140
Medical Device Problem Codes Unstable (1667); Loss of Osseointegration (2408)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, the patient suffered pain and instability; loosening of femur and stem.(left knee) component not revised: advance® ii modular titanium tibial base sz 4 std / product id: kttinp40 / lot number: 085268636.
 
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Brand Name
ADVANCE CANAL FILLING STEM EXTENSION 19MM X 140MM
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11210659
Report Number3010536692-2021-00035
Device Sequence Number17025789
Product Code JWH
UDI-Device IdentifierM684KSP181401
UDI-PublicM684KSP181401
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K973524
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Device Explanted Year2010
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/21/2021
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 NumberKSP18140
Device Catalogue NumberKSP18140
Device Lot Number05346232
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/29/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/29/2020
Initial Report FDA Received Date01/21/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age63 YR
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