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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 Problem Material Disintegration (1177)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to corrosion at the metal-metal junction between the cobalt-chromium modular neck and the titanium stem and the metal debris and ion cast off from the cobalt and chromium conserve femoral head and cobalt and chromium dynasty liner.Modular neck was removed and conserve femoral head was replaced with a polyethylene dual femoral head.
 
Manufacturer Narrative
Correction of implant date.Evaluation codes and the investigation remain as reported initially.
 
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Brand Name
DYNASTY COCR LINER
Type of Device
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10361953
MDR Text Key201578196
Report Number3010536692-2020-00548
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/16/2020
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
Device Operator Other
Device Model NumberDLCOGG44
Device Catalogue NumberDLCOGG44
Device Lot Number059869519
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/13/2020
Initial Date Manufacturer Received 07/13/2020
Initial Date FDA Received08/04/2020
Supplement Dates Manufacturer Received07/13/2020
Supplement Dates FDA Received10/16/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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