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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
Device Problem Loss of Osseointegration (2408)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative

This event will be updated once the investigation is complete. Trends will be evaluated.

 
Event Description

Allegedly, patient was revised due to corrosion at the cocr modular neck and titanium stem, elevated cobalt ions levels and loosening of the acetabular component.

 
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Brand NameDYNASTY® PC SHELL 52MM GROUP D
Type of DeviceHIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key9758308
MDR Text Key181331961
Report Number3010536692-2020-00160
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL NumberDSPCGD52
Device Catalogue NumberDSPCGD52
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/07/2020
Event Location No Information
Date Manufacturer Received02/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/26/2020 Patient Sequence Number: 1
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