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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY A-CLASS 40MM STD GROUP F CROSSLINKED POL; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. DYNASTY A-CLASS 40MM STD GROUP F CROSSLINKED POL; HIP COMPONENT Back to Search Results
Model Number DLXPGF40
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Arthritis (1723)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, patient was revised for liner disassociation.Time to revision was 57 months component not revised: dynasty(r) shell product id: dxxxgf56 lot id: not indicated.Additional information : indication for surgery was osteoarthritis.Bmi: 33.
 
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Brand Name
DYNASTY A-CLASS 40MM STD GROUP F CROSSLINKED POL
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10311825
Report Number3010536692-2020-00498
Device Sequence Number3623650
Product Code JDI
UDI-Device IdentifierM684DLXPGF401
UDI-PublicM684DLXPGF401
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K061547
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other,study
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/28/2020
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 NumberDLXPGF40
Device Catalogue NumberDLXPGF40
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/01/2020
Initial Date Received by Manufacturer 07/01/2020
Supplement Date Received by Manufacturer07/01/2020
Initial Report FDA Received Date07/22/2020
Supplement Report FDA Received Date10/28/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age70 YR
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