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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 DLCOGG44
Device Problems Material Disintegration (1177); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Reaction (2414)
Event Type  Injury  
Event Description
Allegedly the patient was revised due to mom complications: pain; high cocr levels (right). Head, sleeve and neck were explanted. Stryker dual mobility was used with our long 28mm ceramic head and a short modular neck (vv8) was implanted.
 
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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 Key8670676
MDR Text Key147058676
Report Number3010536692-2019-00808
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberDLCOGG44
Device Catalogue NumberDLCOGG44
Device Lot Number119975128
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/30/2019
Event Location No Information
Date Manufacturer Received10/14/2019
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: 06/05/2019 Patient Sequence Number: 1
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