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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY PC SHELL 52MM GROUP D; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. DYNASTY PC SHELL 52MM GROUP D; HIP COMPONENT Back to Search Results
Model Number DSPCGD52
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, cup, liner, screw, head extracted in favor of a stryker revision cup/constrained liner and a mp 22 mm head.Additional information was received on 03/17/2021 from distributor: incident form containing substantial information, also on this day, reason for revision.Allegedly, the patient had dislocated several times.
 
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Brand Name
DYNASTY PC SHELL 52MM GROUP D
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11589405
Report Number3010536692-2021-00185
Device Sequence Number14291945
Product Code LZO
UDI-Device IdentifierM684DSPCGD521
UDI-PublicM684DSPCGD521
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K061547
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/30/2021
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 NumberDSPCGD52
Device Catalogue NumberDSPCGD52
Device Lot Number1765557
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/17/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/17/2021
Initial Report FDA Received Date03/30/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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