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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE CANAL FILLING STEM EXTENSION 18MM X 140MM; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE CANAL FILLING STEM EXTENSION 18MM X 140MM; KNEE COMPONENT Back to Search Results
Model Number KSP17140
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Date of Event 05/28/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
 
Event or Problem Description
Allegedly, patient was revised due to femur implant fractured at the morse taper, the tibial implant was loose, and there was a dissociation of the tibial stem.
 
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Brand Name
ADVANCE CANAL FILLING STEM EXTENSION 18MM X 140MM
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10200696
Report Number3010536692-2020-00432
Device Sequence Number2212510
Product Code JWH
UDI-Device IdentifierM684KSP171401
UDI-PublicM684KSP171401
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K973524
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/03/2020
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 NumberKSP17140
Device Catalogue NumberKSP17140
Device Lot Number1001221772
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/01/2020
Initial Date Received by Manufacturer 06/01/2020
Supplement Date Received by Manufacturer06/01/2020
Initial Report FDA Received Date06/26/2020
Supplement Report FDA Received Date09/03/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
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