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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 28MM GROUP B; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. DYNASTY A-CLASS STD POLY LINER 28MM GROUP B; HIP COMPONENT Back to Search Results
Model Number DLXPGB28
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Insufficient Information (4580)
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, her operating surgeon found a failure of left total hip prosthesis so the patient had to be revised.Components not revised: dynasty® pc shell 48mm group b / product id: dspcgb48 / lot no.: 1657397 profemur® renaissance® classic rdc flare sz11 v8dg short neck / product id: plser011 / lot no.: 1491759.
 
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Brand Name
DYNASTY A-CLASS STD POLY LINER 28MM GROUP B
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key12411246
Report Number3010536692-2021-00488
Device Sequence Number3516787
Product Code JDI
UDI-Device IdentifierM684DLXPGB281
UDI-PublicM684DLXPGB281
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K140043
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/28/2021
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 NumberDLXPGB28
Device Catalogue NumberDLXPGB28
Device Lot Number1648740
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/12/2021
Initial Date Received by Manufacturer 08/12/2021
Supplement Date Received by Manufacturer08/12/2021
Initial Report FDA Received Date09/01/2021
Supplement Report FDA Received Date10/28/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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