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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 Codes Detachment of Device or Device Component (2907); Noise, Audible (3273)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when the investigation is complete.
 
Event or Problem Description
Allegedly patient presented with pain and squeaking sounds, upon x-ray the liner showed disassociation.All mpo implants were explanted and replaced with another manufacturers system, apart from the femoral stem.(b)(4).
 
Additional Manufacturer Narrative
Added device problem code.
 
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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 Key9354114
Report Number3010536692-2019-01145
Device Sequence Number2207814
Product Code LZO
UDI-Device IdentifierM684DSPCGE541
UDI-PublicM684DSPCGE541
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K061547
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/28/2020
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 Number1710095
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/24/2019
Initial Date Received by Manufacturer 10/24/2019
Supplement Date Received by Manufacturer10/24/2019
Initial Report FDA Received Date11/21/2019
Supplement Report FDA Received Date02/28/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age40 YR
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