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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® PC SHELL 56MM GROUP F; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. DYNASTY® PC SHELL 56MM GROUP F; HIP COMPONENT Back to Search Results
Model Number DSPCGF56
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 07/19/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, the device failed due to metal debris corrosion and resultant metal ions, due to the metal on metal design between the articulating surfaces, causing continuing and otherwise irreversible physical injury to the patient.
 
Additional Manufacturer Narrative
Please void this report.Upon investigation it was found not alleged deficiency against this component.The components related to the complaint were captured under reports 3010536692-2019-01030 and 3010536692-2019-0103.
 
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Brand Name
DYNASTY® PC SHELL 56MM GROUP F
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9708312
Report Number3010536692-2019-01029
Device Sequence Number3392541
Product Code LZO
UDI-Device IdentifierM684DSPCGF561
UDI-PublicM684DSPCGF561
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K061547
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/19/2020
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 NumberDSPCGF56
Device Catalogue NumberDSPCGF56
Device Lot Number1628387
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/07/2019
Initial Date Received by Manufacturer 08/07/2019
Supplement Date Received by Manufacturer08/07/2019
Initial Report FDA Received Date02/13/2020
Supplement Report FDA Received Date02/19/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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