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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 Loose or Intermittent Connection (1371)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly, patient presented with pain.Removal of dynasty cup for loosening.No acute injury of patient.Mpo implants were removed and replaced with another suppliers implants.
 
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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 Key9083720
Report Number3010536692-2019-01039
Device Sequence Number16800083
Product Code JDL
UDI-Device IdentifierM684DSBFGD521
UDI-PublicM684DSBFGD521
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K082924
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/31/2020
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 Number1726439
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/21/2019
Initial Date Received by Manufacturer 08/21/2019
Supplement Date Received by Manufacturer08/21/2019
Initial Report FDA Received Date09/18/2019
Supplement Report FDA Received Date01/31/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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