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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® 36MM STD GROUP D CROSSLINKED POL; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® 36MM STD GROUP D CROSSLINKED POL; HIP COMPONENT Back to Search Results
Model Number DLXPGD36
Medical Device Problem Codes Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code No Information (3190)
Date of Event 08/20/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly the surgeon reported that the insert was loose and rolled inside the shell.The cup, insert, head and neck were revised.Head was articulating directly on the shell.Pre-op x-ray and components included.
 
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Brand Name
DYNASTY® A-CLASS® 36MM STD GROUP D CROSSLINKED POL
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9126000
Report Number3010536692-2019-01052
Device Sequence Number2819560
Product Code JDI
UDI-Device IdentifierM684DLXPGD361
UDI-PublicM684DLXPGD361
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K061547
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
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) 06/03/2020
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 NumberDLXPGD36
Device Catalogue NumberDLXPGD36
Device Lot Number1579158
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/28/2019
Initial Date Received by Manufacturer 08/28/2019
Supplement Date Received by Manufacturer08/28/2019
Initial Report FDA Received Date09/26/2019
Supplement Report FDA Received Date06/03/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age48 YR
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