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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GUARDIAN DISTAL FEMUR AXIAL PIN; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. GUARDIAN DISTAL FEMUR AXIAL PIN; KNEE COMPONENT Back to Search Results
Model Number 25002111
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code Loss of Range of Motion (2032)
Date of Event 03/11/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, patient underwent a revision surgery of their hinge knee system.Patient has a lot of co-morbidities and wasn't moving his joint and it stiffened up.Components not revised.25001050, 1557251.25000007, 1643677.
 
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Brand Name
GUARDIAN DISTAL FEMUR AXIAL PIN
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9906531
Report Number3010536692-2020-00307
Device Sequence Number16823856
Product Code JDI
UDI-Device IdentifierM684250021111
UDI-PublicM684250021111
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K013035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/14/2020
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 Number25002111
Device Catalogue Number25002111
Device Lot Number1660384
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/12/2020
Initial Date Received by Manufacturer 03/12/2020
Supplement Date Received by Manufacturer03/12/2020
Initial Report FDA Received Date03/31/2020
Supplement Report FDA Received Date07/14/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age21 YR
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