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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY PC SHELL 54MM GROUP E; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. DYNASTY PC SHELL 54MM GROUP E; HIP COMPONENT Back to Search Results
Model Number DSPCGE54
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
 
Event or Problem Description
Allegedly, patient was revised due to dislocated liner.Components not revised: profemur® renaissance® stem reduced sz 14 product id: pls0r414, lot id: 1750310.Conserve® total medium neck sleeve product id: 38ns0000, lot id: 1723377.Profemur® neck var/val 8dg short cobalt chrome product id: phac1252, lot id: 1736349.
 
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Brand Name
DYNASTY PC SHELL 54MM GROUP E
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10027010
Report Number3010536692-2020-00352
Device Sequence Number2986592
Product Code LZO
UDI-Device IdentifierM684DSPCGE541
UDI-PublicM684DSPCGE541
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K061547
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 07/28/2020
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 NumberDSPCGE54
Device Catalogue NumberDSPCGE54
Device Lot Number1705863
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/15/2020
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date05/05/2020
Supplement Report FDA Received Date07/28/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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