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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® COCR LINER HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. DYNASTY® COCR LINER HIP COMPONENT Back to Search Results
Model Number DLCOGC36
Device Problem Insufficient Information (3190)
Patient Problem Reaction (2414)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to metal on metal complications.
 
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Brand NameDYNASTY® COCR LINER
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 Key9875218
MDR Text Key186293929
Report Number3010536692-2020-00289
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDLCOGC36
Device Catalogue NumberDLCOGC36
Device Lot Number02740608010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/03/2020
Event Location No Information
Date Manufacturer Received03/03/2020
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: 03/24/2020 Patient Sequence Number: 1
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