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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® STD POLY LINER 36MM GROUP E; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® STD POLY LINER 36MM GROUP E; HIP COMPONENT Back to Search Results
Model Number DLXPGE36
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The complaint will be updated once the investigation is completed.Trends will be evaluated.
 
Event or Problem Description
Allegedly the patient underwent right thr on (b)(6) 2019, revised on (b)(6)2019 due to cup mal-positioning.The patient dislocated three times following primary surgery.During revision the same cup was repositioned, flat liner replaced with hooded liner, longer head was used and a screw added.Both procedures were performed through posterior approach.
 
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Brand Name
DYNASTY® A-CLASS® STD POLY LINER 36MM GROUP E
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8623380
Report Number3010536692-2019-00766
Device Sequence Number1654703
Product Code JDI
UDI-Device IdentifierM684DLXPGE361
UDI-PublicM684DLXPGE361
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K070785
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/20/2019
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 NumberDLXPGE36
Device Catalogue NumberDLXPGE36
Device Lot Number1553842
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/13/2019
Initial Date Received by Manufacturer 05/13/2019
Supplement Date Received by Manufacturer05/13/2019
Initial Report FDA Received Date05/20/2019
Supplement Report FDA Received Date07/24/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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