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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® BF SHELL 52MM GROUP D; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. DYNASTY® BF SHELL 52MM GROUP D; HIP COMPONENT Back to Search Results
Model Number DSBFGD52
Medical Device Problem Code Insufficient Device Problem Information (3190)
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 evaluated.
 
Event or Problem Description
Allegedly patient was revised due to unknown reasons.Left hip.
 
Additional Manufacturer Narrative
Please void all reports for medwatch no.3010536692-2020-00018.Updated information on was received on 03/16/2020 that changed the reportability status of this incident.All reports for this medwatch should be voided.
 
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Brand Name
DYNASTY® BF SHELL 52MM GROUP D
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9554802
Report Number3010536692-2020-00018
Device Sequence Number2081990
Product Code JDL
UDI-Device IdentifierM684DSBFGD521
UDI-PublicM684DSBFGD521
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K082924
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 01/06/2020
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 NumberDSBFGD52
Device Catalogue NumberDSBFGD52
Device Lot Number1713433
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/09/2019
Initial Date Received by Manufacturer 12/09/2019
Supplement Date Received by Manufacturer12/09/2019
Initial Report FDA Received Date01/06/2020
Supplement Report FDA Received Date04/28/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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