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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® BF SHELL 54MM GROUP E; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. DYNASTY® BF SHELL 54MM GROUP E; HIP COMPONENT Back to Search Results
Model Number DSBFGE54
Medical Device Problem Codes Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event was reported under: 3010536692-2019-00766 and 3010536692-2019-00768.
 
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® BF SHELL 54MM GROUP E
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9940921
Report Number3010536692-2019-00918
Device Sequence Number19656549
Product Code JDL
UDI-Device IdentifierM684DSBFGE541
UDI-PublicM684DSBFGE541
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K082924
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
Report Date (Section B) 04/08/2020
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 Health Professional
Device Model NumberDSBFGE54
Device Catalogue NumberDSBFGE54
Device Lot Number1777439
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/13/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/13/2019
Initial Report FDA Received Date04/08/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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