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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 Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 07/19/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, the device failed due to metal debris corrosion and resultant metal ions, due to the metal on metal design between the articulating surfaces, causing continuing and otherwise irreversible physical injury to the patient.
 
Additional Manufacturer Narrative
Please void this report.Upon investigation it was found not alleged deficiency against this component.The components related to the complaint were captured under reports 3010536692-2019-01030 and 3010536692-2019-0103.
 
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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 Key9708245
Report Number3010536692-2020-00111
Device Sequence Number17044830
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
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/19/2020
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
Device Lot Number1638225
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/07/2019
Initial Date Received by Manufacturer 08/07/2019
Supplement Date Received by Manufacturer08/07/2019
Initial Report FDA Received Date02/13/2020
Supplement Report FDA Received Date02/19/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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