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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 DLCOGE40
Device Problem Material Disintegration (1177)
Patient Problem Reaction (2414)
Event Type  Injury  
Event Description
Allegedly the patient was revised due to mom complications: metallosis; pseudo-tumor. (left). Liner and head were removed and replaced with a ceramic head and poly liner (36mm).
 
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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 Key8754949
MDR Text Key149843716
Report Number3010536692-2019-00890
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDLCOGE40
Device Catalogue NumberDLCOGE40
Device Lot Number0401096841
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/28/2019
Event Location No Information
Date Manufacturer Received06/28/2019
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: 07/02/2019 Patient Sequence Number: 1
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