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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GUARDIAN® TIBIAL HINGE BASE W/ ROTATIONAL STOP PIN; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. GUARDIAN® TIBIAL HINGE BASE W/ ROTATIONAL STOP PIN; KNEE COMPONENT Back to Search Results
Model Number 25002100
Medical Device Problem Code Unstable (1667)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly the patient was revised due to instability.The hinge components were in two pieces-the stem separated from the base.Dr (b)(6) revised the axial pin, hinge component, and 8mm poly.
 
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Brand Name
GUARDIAN® TIBIAL HINGE BASE W/ ROTATIONAL STOP PIN
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8848820
Report Number3010536692-2019-00927
Device Sequence Number11353175
Product Code JDI
UDI-Device IdentifierM684250021001
UDI-PublicM684250021001
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K013035
Number of Events Summarized1
Summary Report (Y/N)N
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) 01/27/2020
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 Number25002100
Device Catalogue Number25002100
Device Lot Number1613563
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/01/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/01/2019
Supplement Date Received by Manufacturer07/01/2019
Initial Report FDA Received Date07/31/2019
Supplement Report FDA Received Date01/27/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age50 YR
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