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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY BF SHELL PRIMARY 52MM GROUP D; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. DYNASTY BF SHELL PRIMARY 52MM GROUP D; HIP COMPONENT Back to Search Results
Model Number DBFPGD52
Medical Device Problem Codes Failure to Osseointegrate (1863); Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, right leg is short, cup is too vertical, patient has dislocated 3 times and there is lucency around the cup to indicated that it has poor in growth.Cup, screws /liner/head/neck were pulled.Stryker cup went in with our head and neck.
 
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Brand Name
DYNASTY BF SHELL PRIMARY 52MM GROUP D
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10341205
Report Number3010536692-2020-00531
Device Sequence Number3065699
Product Code JDI
UDI-Device IdentifierM684DBFPGD521
UDI-PublicM684DBFPGD521
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K122382
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/29/2020
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 Health Professional
Device Model NumberDBFPGD52
Device Catalogue NumberDBFPGD52
Device Lot Number1634559
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/06/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/06/2020
Initial Report FDA Received Date07/29/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age70 YR
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